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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K903030
Device Name SOPHYCAMERA DSM 315
Applicant
Provino
Jellingvej5
Dk-9230 Svenstrup
Denmark,  DK
Applicant Contact HANS HARDING
Correspondent
Provino
Jellingvej5
Dk-9230 Svenstrup
Denmark,  DK
Correspondent Contact HANS HARDING
Regulation Number892.1100
Classification Product Code
IYX  
Date Received07/10/1990
Decision Date 10/29/1990
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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