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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K853561
Device Name LIFESTAT 100
Applicant
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact GAIL NOVA
Correspondent
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact GAIL NOVA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/26/1985
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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