FDA 510(k) Application Details - K092999

Device Classification Name Blood Pressure Cuff

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510(K) Number K092999
Device Name Blood Pressure Cuff
Applicant DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford, PA 18969 US
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Contact JOYCE KILROY
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/28/2009
Decision Date 11/24/2009
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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