FDA 510(k) Application Details - K022596

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K022596
Device Name Computer, Diagnostic, Programmable
Applicant CLOVER HI-TECH INC.
17800 CASTLETON ST.
SUITE 415
CITY OF INDUSTRY, CA 91748 US
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Contact CECILIA L YU
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 08/05/2002
Decision Date 01/31/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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