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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 K897074
Device Name MODEL 215M PATIENT SIMULATOR
Applicant
Dynatech/Nevada, Inc.
2000 Arrowhead Dr.
Carson City,  NV  89706
Applicant Contact D HENDRICKS
Correspondent
Dynatech/Nevada, Inc.
2000 Arrowhead Dr.
Carson City,  NV  89706
Correspondent Contact D HENDRICKS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/22/1989
Decision Date 05/17/1990
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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