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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K790144
Device Name TELEMETRY SYSTEM 315
Applicant
Ge Medical Systems Information Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ge Medical Systems Information Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2910
Classification Product Code
DRG  
Date Received01/19/1979
Decision Date 02/23/1979
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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