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FDA 510(k) Application Details - K173973
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K173973
Device Name
Ventilator, Continuous, Facility Use
Applicant
Bio-Med Devices, Inc.
61 Soundview Road
Guilford, CT 06437 US
Other 510(k) Applications for this Company
Contact
Ken Close
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2017
Decision Date
07/20/2018
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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