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FDA 510(k) Application Details - K092037
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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510(K) Number
K092037
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant
HOANA MEDICAL, INC.
21031 SE 202ND STREET
RENTON, WA 98058 US
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Contact
Cindy Green
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Regulation Number
870.2300
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Classification Product Code
DRT
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Date Received
07/06/2009
Decision Date
10/02/2009
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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