FLAT VASCULAR PROBE

Flowmeter, Blood, Cardiovascular

IMEX MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK896613
510k NumberK896613
Device Name:FLAT VASCULAR PROBE
ClassificationFlowmeter, Blood, Cardiovascular
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 CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-21
Decision Date1990-02-16

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