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510(k) K203635

Patient Monitoring Cables by Jkh USA, LLC — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2021
Date Received
December 14, 2020
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

Other clearances by Jkh USA, LLC

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  • K191151 — JKH Stimulator Plus (June 21, 2019)
  • K182203 — JKH Stimulator Plus (March 14, 2019)

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