WR19 System

Full-montage Standard Electroencephalograph

Zeto, Inc.

The following data is part of a premarket notification filed by Zeto, Inc. with the FDA for Wr19 System.

Pre-market Notification Details

Device IDK172735
510k NumberK172735
Device Name:WR19 System
ClassificationFull-montage Standard Electroencephalograph
Applicant Zeto, Inc. 2336 Park Ave Santa Clara,  CA  95050
ContactAswin Gunasekar
CorrespondentDonna-bea Tillman
Biologics Consulting Group 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-11
Decision Date2018-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B675WR190 K172735 000
B675DRYFLEXM2 K172735 000
B675DRYFLEXT2 K172735 000
B675SILVERFLATSOFTS1 K172735 000
B675SILVERFLEXSOFTM1 K172735 000
B675SILVERFLEXSOFTS1 K172735 000
B675SILVERFLEXSOFTT1 K172735 000
B675SOFTFLATS1 K172735 000
B675SOFTFLATT2 K172735 000
B675SOFTFLEXM1 K172735 000
B675SOFTFLEXS1 K172735 000
B675SOFTFLEXT1 K172735 000
B675DRYFLATS02 K172735 000

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