MODIFICATION TO VIEWMATE SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

EP MEDSYSTEMS

The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Modification To Viewmate System.

Pre-market Notification Details

Device IDK073709
510k NumberK073709
Device Name:MODIFICATION TO VIEWMATE SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin,  NJ  08091
ContactLarry Picciano
CorrespondentLarry Picciano
EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin,  NJ  08091
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-03-11
Summary:summary

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