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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K851149
Device Name KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
Applicant
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Applicant Contact ROGER GRAY
Correspondent
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Correspondent Contact ROGER GRAY
Regulation Number892.1540
Classification Product Code
JAF  
Date Received03/21/1985
Decision Date 11/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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