FDA 510(k) Application Details - K200988

Device Classification Name Device, Positive Pressure Breathing, Intermittent

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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
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Regulation Number 868.5905

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Classification Product Code NHJ
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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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