FDA 510(k) Application Details - K122063

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K122063
Device Name Gas-Machine, Anesthesia
Applicant PHILIPS ANESTHESIA CARE
ISLEVDALVEJ 211
RODOVRE 2610 DK
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Contact NEIL BATTISTE
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 07/13/2012
Decision Date 08/02/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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