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510(k) K211941

9Line by Energetic Designs, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
June 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

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