FDA 510(k) Application Details - K192143

Device Classification Name	Device, Positive Pressure Breathing, Intermittent   More FDA Info for this Device
510(K) Number	K192143
Device Name	Device, Positive Pressure Breathing, Intermittent
Applicant	Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore SG Other 510(k) Applications for this Company
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	08/08/2019
Decision Date	02/14/2020
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