FDA 510(k) Application Details - K092864

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K092864
Device Name Gas-Machine, Anesthesia
Applicant DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
PO BOX 7550
3030 OHMEDA DRIVE
MADISON, WI 53707-7550 US
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Contact ADRIENNE LENZ
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 09/17/2009
Decision Date 01/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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