FDA 510(k) Application Details - K033646

Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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510(K) Number K033646
Device Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant HEALTHFIRST CORP.
13170-B CENTRAL AVE SE
SUITE 115
ALBUQUERQUE, NM 87123 US
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Contact JAY SKOLNIK
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Regulation Number 870.2300

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Classification Product Code DRT
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Date Received 11/20/2003
Decision Date 03/01/2005
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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