KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1

Monitor, Ultrasonic, Nonfetal

KEYMED, INC.

The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Key Med Transendoscopic Vascular Detector Tvd-1.

Pre-market Notification Details

Device IDK851149
510k NumberK851149
Device Name:KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
ClassificationMonitor, Ultrasonic, Nonfetal
Applicant KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England,  GB
ContactRoger Gray
CorrespondentRoger Gray
KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England,  GB
Product CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-21
Decision Date1985-11-26

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