FDA 510(k) Application Details - K990058

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K990058
Device Name Computer, Diagnostic, Programmable
Applicant CATHDATA, INC.
1151 HOPE ST.
STAMPFORD, CT 06907 US
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Contact RICHARD KEEN
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 01/07/1999
Decision Date 12/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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