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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K830876
Device Name PREP-CHECK
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 Number870.2370
Classification Product Code
KRC  
Date Received03/18/1983
Decision Date 05/18/1983
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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