Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM

Device, Iontophoresis, Specific Uses

WR MEDICAL ELECTRONICS CO.

The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Q-sweat Quantitative Sweat Measurement System.

Pre-market Notification Details

Device IDK992874
510k NumberK992874
Device Name:Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
ClassificationDevice, Iontophoresis, Specific Uses
Applicant WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater,  MN  55082
ContactPatrick J Anderson
CorrespondentPatrick J Anderson
WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater,  MN  55082
Product CodeKTB  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-26
Decision Date1999-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00702173151885 K992874 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.