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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K844650
Device Name DR-2C
Applicant
General Devices
86 Harriet Ave.
Bergenfield,  NJ  07621
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
86 Harriet Ave.
Bergenfield,  NJ  07621
Correspondent Contact MICHAEL SMITH
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received11/29/1984
Decision Date 01/22/1985
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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