FDA 510(k) Application Details - K031027

Device Classification Name Vaporizer, Anesthesia, Non-Heated

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510(K) Number K031027
Device Name Vaporizer, Anesthesia, Non-Heated
Applicant DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON, WI 53707-7550 US
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Contact WILLIAM E EXNER
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Regulation Number 868.5880

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Classification Product Code CAD
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Date Received 04/01/2003
Decision Date 06/26/2003
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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