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510(k) K200722

PCA-C1 series Patient Cable by QT Medical, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2021
Date Received
March 19, 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 QT Medical, Inc.

  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • K220795 — QT ECG (September 26, 2022)
  • K180157 — QT ECG (May 4, 2018)

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