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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 K860361
Device Name DIASONICS 3.5 GWA 30MM PROBE
Applicant
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Applicant Contact FERNANDEZ JR.
Correspondent
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Correspondent Contact FERNANDEZ JR.
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/30/1986
Decision Date 05/27/1986
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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