IMEX 8000 PERSONAL CASCULAR LAB

System, Imaging, Pulsed Echo, Ultrasonic

IMEX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imex 8000 Personal Cascular Lab.

Pre-market Notification Details

Device IDK942243
510k NumberK942243
Device Name:IMEX 8000 PERSONAL CASCULAR LAB
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
ContactDennis Newman
CorrespondentDennis Newman
IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden,  CO  80403
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-09
Decision Date1995-11-03

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