FDA 510(k) Application Details - K124032

Device Classification Name Device, Positive Pressure Breathing, Intermittent

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510(K) Number K124032
Device Name Device, Positive Pressure Breathing, Intermittent
Applicant HILL-ROM SERVICES PTE LTD
1 YISHUN AVE 7
SINGAPORE 768923 SG
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Contact PAUL DRYDEN
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Regulation Number 868.5905

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Classification Product Code NHJ
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Date Received 12/28/2012
Decision Date 04/25/2013
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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