Home / 510(k) Clearances / K243545

510(k) K243545

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn by Philips Medizin Systeme Böblingen GmbH — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
November 15, 2024
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 Philips Medizin Systeme Böblingen GmbH

  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K221348 — IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (8664 (February 3, 2023)
  • K211900 — Patient Information Center iX (March 4, 2022)

Other clearances for product code DSA

  • K254114 — Baylis Connector Cable (January 18, 2026)
  • K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abb (December 1, 2025)
  • K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, (September 30, 2025)
  • K242986 — SpO2 Extension Cable (May 2, 2025)
  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K240377 — LIFEPAK® ECG Cables (May 7, 2024)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K222712 — Fogg System Patient Monitoring Cables (November 22, 2023)
  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)
  • K222370 — SpO2 Extension Cable (April 2, 2023)