510(k) K203635

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

K203635 is an FDA 510(k) premarket notification submitted by Jkh USA, LLC for the device "Patient Monitoring Cables". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Jkh USA, LLC has at least 8 other 510(k) clearances on record.

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