Zeto ONE HEOG Cable Extension Set

GUDID B675ONEHEOG1

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

Electroencephalograph
Primary Device IDB675ONEHEOG1
NIH Device Record Key5826f450-48dd-4204-abaf-d2c9b4d70762
Commercial Distribution StatusIn Commercial Distribution
Brand NameZeto ONE HEOG Cable Extension Set
Version Model NumberZP-230-30031
Company DUNS079582566
Company NameZETO INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com
Phone8339386334
Emailsupport@zetoinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675ONEHEOG1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-19
Device Publish Date2024-06-11

Devices Manufactured by ZETO INC

B675DC0 - Zeto ONE Disinfection Container with Lid2024-11-28 The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription u
B675MM0 - Zeto All-in-One Medical Grade PC2024-11-28 The "Zeto All-in-One Medical Grade PC" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in
B675ONEAUX1 - Zeto ONE AUX Cable Extension Set2024-06-19 The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEDU0 - Zeto ONE Display Unit2024-06-19 The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare fac
B675ONEECG1 - Zeto ONE ECG Cable Extension Set2024-06-19 The Zeto ONE ECG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEEMG1 - Zeto ONE EMG Cable Extension Set2024-06-19 The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
B675ONEESB1 - Zeto ONE Electrode Set — Basic2024-06-19 The Zeto ONE Electrode Set — Basic is a part of the Zeto ONE, which is an EEG system intended for prescription use in a health
B675ONEHEOG1 - Zeto ONE HEOG Cable Extension Set2024-06-19The 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.
B675ONEHEOG1 - Zeto ONE HEOG Cable Extension Set2024-06-19 The Zeto ONE HEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in h

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.