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FDA 510(k) Application Details - K200988
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
More FDA Info for this Device
510(K) Number
K200988
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
Alvin Tan
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
04/15/2020
Decision Date
05/26/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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