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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 K211941
Device Name 9Line
Applicant
Energetic Designs, Inc.
3037 Grizzly Peak Dr.
Broomfield,  CO  80023
Applicant Contact Kathy Fortin
Correspondent
FDA 510k Consultants, LLC
1100 Del Lago Circle #104
Palm Beach Gardens,  FL  33410
Correspondent Contact John F. Gillespy
Regulation Number870.2900
Classification Product Code
DSA  
Date Received06/23/2021
Decision Date 01/27/2022
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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