WR19

GUDID B675WR190

EEG Headset

ZETO INC

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph
Primary Device IDB675WR190
NIH Device Record Key31ce5e1a-f685-4cfc-a7b9-ae212a464bd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameWR19
Version Model NumberZP-100-11001
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 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

Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675WR190 [Primary]
HIBCCB675WR191 [Package]
Package: case [1 Units]
In Commercial Distribution

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-03-23
Device Publish Date2019-08-15

Devices Manufactured by ZETO INC

B675WR190 - WR192023-03-23EEG Headset
B675WR190 - WR192023-03-23 EEG Headset
B675SILVERFLEXSOFTM1 - Silver-Flex-Soft-M2022-04-29 Soft Flex Electrodes - Medium
B675DRYFLATS02 - Dry Flat-S2021-02-02 Dry Flat Electrode - Short
B675DRYFLEXM2 - Dry Flex-M2021-02-02 Dry Flex Electrode - Bristle, Medium
B675DRYFLEXT2 - Dry Flex-T2021-02-02 Dry Flex Electrodes - Bristle Tall
B675SOFTFLATT2 - Soft Flat-T2021-02-02 Soft Flat Electrodes - Tall
B675SOFTFLATS1 - Soft Flat-S 2019-10-28 Soft Flat Electrodes - Short
B675SOFTFLEXM1 - Soft Flex-M2019-10-28 Soft Flex Electrodes - Medium
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.