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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K915860
Device Name LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
Applicant
Biosound, Inc.
6110 Bollinger Rd.
San Jose,  CA  95129
Applicant Contact WILLIAM E MCKAY
Correspondent
Biosound, Inc.
6110 Bollinger Rd.
San Jose,  CA  95129
Correspondent Contact WILLIAM E MCKAY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/30/1991
Decision Date 07/02/1992
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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