FDA 510(k) Application Details - K000411

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K000411
Device Name Digitizer, Image, Radiological
Applicant STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK
24 EASTMAN AVE. C5
BEDFORD, NH 03110 US
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Contact JIM DOYLE
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 02/08/2000
Decision Date 04/14/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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