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FDA 510(k) Application Details - K102525
Device Classification Name
Mechanical Ventilator
More FDA Info for this Device
510(K) Number
K102525
Device Name
Mechanical Ventilator
Applicant
BREATHE TECHNOLOGIES, INC.
1193 SHERMAN ST.
ALAMEDA, CA 94501 US
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CRAIG COOMBS
Other 510(k) Applications for this Contact
Regulation Number
868.5895
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Classification Product Code
ONZ
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More FDA Info for this Product Code
Date Received
09/02/2010
Decision Date
12/02/2010
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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