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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K880714
Device Name DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
Applicant
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Applicant Contact THOMAS ALBRIGHT
Correspondent
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Correspondent Contact THOMAS ALBRIGHT
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/22/1988
Decision Date 04/21/1988
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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