FDA 510(k) Application Details - K992467

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K992467
Device Name Digitizer, Image, Radiological
Applicant DBA SYSTEMS, INC.
555 13TH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 07/23/1999
Decision Date 02/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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