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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 K897098
Device Name SIEMENS ENDO-P-PROBE
Applicant
Siemens Medical Solutions USA, Inc.
2527 Camino Ramon
San Ramon,  CA  94583
Applicant Contact K JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
2527 Camino Ramon
San Ramon,  CA  94583
Correspondent Contact K JOHNSON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/21/1989
Decision Date 02/23/1990
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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