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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K222712
Device Name Fogg System Patient Monitoring Cables
Applicant
Fogg System Company, Inc.
15592 E. Batavia Dr.
Aurora,  CO  80011
Applicant Contact Ken Neef
Correspondent
Novare Medical Consulting, LLC
1765 Dusty Boot Dr.
Lafayette,  CO  80026
Correspondent Contact Jared Walkenhorst
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/08/2022
Decision Date 11/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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