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FDA 510(k) Application Details - K151689
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
More FDA Info for this Device
510(K) Number
K151689
Device Name
Device, Positive Pressure Breathing, Intermittent
Applicant
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore 768923 SG
Other 510(k) Applications for this Company
Contact
Huifang Zhu
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
NHJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2015
Decision Date
03/17/2016
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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