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FDA 510(k) Application Details - K102054
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K102054
Device Name
Ventilator, Continuous, Facility Use
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD, CA 92011 US
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Contact
TAMATHA LEY
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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
07/22/2010
Decision Date
12/22/2010
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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