IMEX STETHODOP

Monitor, Ultrasonic, Nonfetal

IMEX MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK973336
510k NumberK973336
Device Name:IMEX STETHODOP
ClassificationMonitor, Ultrasonic, Nonfetal
Applicant IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
ContactDavid W Wagner
CorrespondentDavid W Wagner
IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
Product CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-04
Decision Date1998-02-05

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