FDA 510(k) Application Details - K132530

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K132530
Device Name Gas-Machine, Anesthesia
Applicant DATEX-OHMEDA, INC.
3030 Ohmeda Dr
MADISON, WI 53718 US
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Contact JAMES P RASKOB
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 08/12/2013
Decision Date 12/20/2013
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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