Zeto ONE Head Unit - Regular

GUDID B675ONEHUL1

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

Electroencephalograph
Primary Device IDB675ONEHUL1
NIH Device Record Keya4169b82-3ea7-43aa-8062-11e1948e93f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameZeto ONE Head Unit - Regular
Version Model NumberZP-120-11031
Company DUNS079582566
Company NameZETO INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675ONEHUL1 [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 Date2025-07-17
Device Publish Date2025-07-09

Devices Manufactured by ZETO INC

B675ONEHUL1 - Zeto ONE Head Unit - Regular2025-07-17The 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.
B675ONEHUL1 - Zeto ONE Head Unit - Regular2025-07-17 The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in h
B675ONEHUS1 - Zeto ONE Head Unit - Small2025-07-17 The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in hea
B675ONELTES1 - Zeto ONE Long-Term Electrode Set2025-07-17 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 health
B675ONESTES1 - Zeto ONE Short-Term Electrode Set2025-07-17 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 healt
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

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