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FDA 510(k) Application Details - K190533
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K190533
Device Name
Ventilator, Continuous, Facility Use
Applicant
Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 US
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Contact
Jennifer Kennedy
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
03/04/2019
Decision Date
07/26/2019
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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