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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K896153
Device Name MODIFIED DR-2C/PMC 100
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 Number870.2800
Classification Product Code
DSH  
Date Received10/24/1989
Decision Date 01/19/1990
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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