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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 K881208
Device Name PROBE SHEATH FOR ADMS ULTRASOUND PROBE
Applicant
Advanced Diagnostic Medical Systems, Inc.
6905 Sierra Ct.
Dublin,  CA  94568
Applicant Contact J ALLSEBROOK
Correspondent
Advanced Diagnostic Medical Systems, Inc.
6905 Sierra Ct.
Dublin,  CA  94568
Correspondent Contact J ALLSEBROOK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/21/1988
Decision Date 05/16/1988
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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