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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K851916
Device Name VSM MODELS A & B
Applicant
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact GAIL E NOVA
Correspondent
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact GAIL E NOVA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received05/02/1985
Decision Date 08/19/1985
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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