FDA 510(k) Application Details - K102033

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K102033
Device Name Transducer, Blood-Pressure, Extravascular
Applicant B. BRAUN MELSUNGEN AG
901 MARCON BLVD
ALLENTOWN, PA 18109 US
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Contact LISA GIAQUINTO
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 07/19/2010
Decision Date 04/07/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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