FDA 510(k) Application Details - K172702

Device Classification Name Vaporizer, Anesthesia, Non-Heated

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510(K) Number K172702
Device Name Vaporizer, Anesthesia, Non-Heated
Applicant Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison, WI 53707-7550 US
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Contact Trishia Mercier
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Regulation Number 868.5880

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Classification Product Code CAD
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Date Received 09/07/2017
Decision Date 01/04/2018
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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