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FDA 510(k) Application Details - K951246
Device Classification Name
Monitor, Apnea, Facility Use
More FDA Info for this Device
510(K) Number
K951246
Device Name
Monitor, Apnea, Facility Use
Applicant
PROTOCOL SYSTEMS, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON, OR 97008-7101 US
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Contact
JAMES P WELCH
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Regulation Number
868.2377
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Classification Product Code
FLS
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More FDA Info for this Product Code
Date Received
03/20/1995
Decision Date
02/02/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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