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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K840020
Device Name FITNESS LOGGER
Applicant
Britt Corp., Inc.
Chanhassen,  MN  55317
Applicant Contact AXEL M FRITZ
Correspondent
Britt Corp., Inc.
Chanhassen,  MN  55317
Correspondent Contact AXEL M FRITZ
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/05/1984
Decision Date 10/26/1984
Decision SE - Postmarket Surveillance Required (SESP)
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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