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FDA 510(k) Application Details - K124032
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
NHJ
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More FDA Info for this Product Code
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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