FDA 510(k) Application Details - K103035

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K103035
Device Name Gas-Machine, Anesthesia
Applicant DRAEGER MEDICAL GMBH
3135 Quarry Road
Telford, PA 18969 US
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Contact JOYCE KILROY
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 10/13/2010
Decision Date 03/28/2012
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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