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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 K921296
Device Name ADAC S315
Applicant
Adac Laboratories
Jellingvej 5
9230 Svenstrup
Denmark,  DK
Applicant Contact JEPPE VANGSGAARD
Correspondent
Adac Laboratories
Jellingvej 5
9230 Svenstrup
Denmark,  DK
Correspondent Contact JEPPE VANGSGAARD
Regulation Number892.1100
Classification Product Code
IYX  
Date Received03/17/1992
Decision Date 05/28/1992
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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