EPCOM EMS SCAN II

System, Imaging, Pulsed Echo, Ultrasonic

EPCOM MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Epcom Ems Scan Ii.

Pre-market Notification Details

Device IDK813275
510k NumberK813275
Device Name:EPCOM EMS SCAN II
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant EPCOM MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-23
Decision Date1982-03-31

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