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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K844464
Device Name PROGRAMMABLE PATIENT SIMULATOR
Applicant
Ramford Labs
809 Camellia
Escondido,  CA  92027
Applicant Contact RALPH D CLIFFORD
Correspondent
Ramford Labs
809 Camellia
Escondido,  CA  92027
Correspondent Contact RALPH D CLIFFORD
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/20/1984
Decision Date 04/03/1985
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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