FDA 510(k) Application Details - K951246

Device Classification Name Monitor, Apnea, Facility Use

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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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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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