ECOGEL 200 ULTRASOUND GEL

Transducer, Ultrasonic, Diagnostic

ECO-MED PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecogel 200 Ultrasound Gel.

Pre-market Notification Details

Device IDK955246
510k NumberK955246
Device Name:ECOGEL 200 ULTRASOUND GEL
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario,  CA L4w 1h3
ContactPaul L Hooey
CorrespondentPaul L Hooey
ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario,  CA L4w 1h3
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-15
Decision Date1996-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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