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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 K912008
Device Name TRU-VIEW MULTI-CHANNEL DISPLAY
Applicant
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Correspondent Contact MICHAEL SMITH
Regulation Number870.2300
Classification Product Code
DRT  
Date Received05/06/1991
Decision Date 10/09/1991
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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