WR19

GUDID B675WR190

Electroencephalograph

Primary Device ID	B675WR190
NIH Device Record Key	31ce5e1a-f685-4cfc-a7b9-ae212a464bd5
Commercial Distribution Status	In Commercial Distribution
Brand Name	WR19
Version Model Number	ZP-100-11001
Company DUNS	079582566
Company Name	ZETO INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B675WR190 [Primary]
HIBCC	B675WR191 [Package] Package: case [1 Units] In Commercial Distribution

GWQ	Full-Montage Standard Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

B675ONEHUL1 - Zeto ONE Head Unit - Regular	2025-07-17 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 - Small	2025-07-17 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 Set	2025-07-17 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 Set	2025-07-17 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 Lid	2024-11-28 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 PC	2024-11-28 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 Set	2024-06-19 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 Unit	2024-06-19 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