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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, apnea, facility use
510(k) Number K951246
Device Name PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
Applicant
PROTOCOL SYSTEMS, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7101
Applicant Contact JAMES P WELCH
Correspondent
PROTOCOL SYSTEMS, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7101
Correspondent Contact JAMES P WELCH
Regulation Number868.2377
Classification Product Code
FLS  
Subsequent Product Codes
DRT   MHX  
Date Received03/20/1995
Decision Date 02/02/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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