MASCOT STETHOSCOPE PROBE

Stethoscope, Electronic

IMEX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Mascot Stethoscope Probe.

Pre-market Notification Details

Device IDK874726
510k NumberK874726
Device Name:MASCOT STETHOSCOPE PROBE
ClassificationStethoscope, Electronic
Applicant IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
ContactEd Bistrick
CorrespondentEd Bistrick
IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-18
Decision Date1988-03-31

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