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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 K870967
Device Name ADMS TRANSRECTAL 7.5 MHZ PROBE
Applicant
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Applicant Contact GARY M AGATEP
Correspondent
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Correspondent Contact GARY M AGATEP
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/10/1987
Decision Date 09/29/1987
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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