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FDA 510(k) Application Details - K062224
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K062224
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
RESPCARE INC.
6601 LYONS ROAD, SUITES B1-B4
COCONUT CREEK, FL 33073 US
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Contact
FRANK PELC
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
08/02/2006
Decision Date
08/17/2006
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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