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FDA 510(k) Application Details - K112220
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K112220
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
DEVILBISS HEALTHCARE LLC
100 DEVILBISS HEALTHCARE
SOMERSET, PA 15501 US
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Contact
JAMES P FROEHLICH
Other 510(k) Applications for this Contact
Regulation Number
868.5905
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Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2011
Decision Date
11/22/2011
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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