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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K001841
Device Name 35/CD CINECONVERTER
Applicant
Tagarno A/S
Hattingvej 5
Horsens,  DK 8700
Applicant Contact MAX JENS JENSEN
Correspondent
Tagarno A/S
Hattingvej 5
Horsens,  DK 8700
Correspondent Contact MAX JENS JENSEN
Regulation Number892.2030
Classification Product Code
LMA  
Date Received06/19/2000
Decision Date 11/15/2000
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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