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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 K160667
Device Name Anybattery C2 Rechargeable Battery
Applicant
Anybattery, Inc.
2605 160th St. W #16
Rosemont,  MN  55068
Applicant Contact Ed Speegle
Correspondent
Denterprise International, Inc. / 510k FDA Consulting
100 E. Granade Blvd., Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DRT   DXN   LDD   MHX   MWI  
Date Received03/09/2016
Decision Date 05/11/2017
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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