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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 K961002
Device Name DIASONICS ITNRAOPERATIVE PROBES
Applicant
Diasonics Ultrasound
2860 Dela Cruz Blvd.
Santa Clara,  CA  95050
Applicant Contact JERRY W TSUTSUMI
Correspondent
Diasonics Ultrasound
2860 Dela Cruz Blvd.
Santa Clara,  CA  95050
Correspondent Contact JERRY W TSUTSUMI
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/12/1996
Decision Date 01/22/1997
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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