FDA.reportPublic FDA data

Zeto EU Kft.

Matched from indexed company URL: Zeto, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30179703073017970307Zeto EU Kft.1N2026-01-01Zoltan Utca 6 Szeged HU 6724
30218260573021826057ZETO, INC.1Y2026-01-015565 Centerview Dr Ste 105 Raleigh NC US 27606
30145452753014545275ZETO, INC.1N2020-04-254701 Patrick Henry Dr, Bldg #23 Santa Clara CA US 95054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B675DRYFLATS1Dry Flat-S - Dry Flat Electrode - Short8339386334info@zetoinc.com
B675DRYFLEXM1Dry Flex-M - Dry Flex Electrode - Bristle, Medium8339386334info@zetoinc.com
B675DRYFLEXT1Dry Flex-T - Dry Flex Electrodes - Bristle Tall8339386334info@zetoinc.com
B675ONEHUL0Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.8339386334support@zetoinc.com
B675ONEHUL1Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.8339386334support@zetoinc.com
B675ONEHUS0Zeto ONE Head Unit - Small - The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.8339386334support@zetoinc.com
B675PDDU0Zeto ONE Display Unit - The Zeto ONE Display Unit (DU) is a part of the Zeto ONE system, which is an EEG system intended to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. Perscription use only.The Display Unit is the parent device of the Flexset System, intended to:power the Zeto ONE Head Unit.aquire the Zeto ONE Head Unit's signalstransmit the obtained data to the Zeto Cloud Platformdisplay the currently detected EEG signalscontrol the recording processThe Display Unit is supplied with a USB power delivery-capable charger and an appropriate type C charging cable.8339386334support@zetoinc.com
B675SOFTFLATT1Soft Flat-T - Soft Flat Electrodes - Tall8339386334info@zetoinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2875821154753823K233403Flexset SystemGWQ2024-04-30
3025231154753823K233403Flexset SystemGWQ2024-04-30
2189841865510769K172735WR19 SystemGWQ2018-04-17
2875821865510769K172735WR19 SystemGWQ2018-04-17
3025231865510769K172735WR19 SystemGWQ2018-04-17
2189841507336353

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWQ52024-04-30

PMN#

GUDID#

Zeto ONE Display Unit - The Zeto ONE Display Unit (DU) is a part of the Zeto ONE system, which is an EEG system intended to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. Perscription use only.The Display Unit is the parent device of the Flexset System, intended to:power the Zeto ONE Head Unit.aquire the Zeto ONE Head Unit's signalstransmit the obtained data to the Zeto Cloud Platformdisplay the currently detected EEG signalscontrol the recording processThe Display Unit is supplied with a USB power delivery-capable charger and an appropriate type C charging cable.

ZETO, INC.

2025-11-19

Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

ZETO, INC.

2026-03-13

Zeto ONE Head Unit - Small - The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

ZETO, INC.

2026-03-13

Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

ZETO, INC.

2025-07-09

Zeto ONE Head Unit - Small - The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

ZETO, INC.

2025-07-09

Zeto ONE Long-Term Electrode Set - "The Zeto ONE Long-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Long-Term electrode set contains 17 ""Soft Flex"" electrodes, 3 ""Soft Flat"" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session."

ZETO, INC.

2025-07-09

Zeto ONE Short-Term Electrode Set - "The Zeto ONE Short-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The short term electrode set contains 17 ""Soft Flex"" electrodes, 3 ""Soft Flat"" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session, that is shorter than 90 minutes."

ZETO, INC.

2025-07-09

Zeto ONE Disinfection Container with Lid - The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Disinfection Container is plastic bowl with a special geometry and a purpose built lid. It is intended to hold the Zeto ONE headset in a disinfecting liquid for reprocessing.

ZETO, INC.

2024-11-20

Zeto ONE AUX Cable Extension Set - The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The AUX Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record auxiliary signals.

ZETO, INC.

2024-06-11

Zeto ONE Display Unit - The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Display Unit is the parent device of the Flexset System, intended to:- power the Zeto ONE Head Unit.- aquire the Zeto ONE Head Unit's signals- transmit the obtained data to the Zeto Cloud Platform- display the currently detected EEG signals- control the recording process

ZETO, INC.

2024-06-11

Zeto ONE ECG Cable Extension Set - The Zeto ONE ECG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The ECG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record electrocardiogram signals.

ZETO, INC.

2024-06-11

Zeto ONE EMG Cable Extension Set - The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The EMG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record electromyoogram signals.

ZETO, INC.

2024-06-11

Zeto ONE HEOG Cable Extension Set - The Zeto ONE HEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The HEOG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record horizontal electrooculogram signals.

ZETO, INC.

2024-06-11

Zeto ONE REF Cable Extension - The Zeto ONE REF Cable Extension is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The REF Cable Extension is a lead wire with 2.5 mm jack connector at one end, and a snap-on connector for commonly available adhesive electrodes at the other end. The lead wire is used as a reference cable during EEG recording sessions.

ZETO, INC.

2024-06-11

Zeto ONE VEOG Cable Extension Set - The Zeto ONE VEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The VEOG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record vertical electrooculogram signals.

ZETO, INC.

2024-06-11