Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC +9 more— 510(k) K243545

Clearance details

Device name as filed

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

Applicant

Philips Medizin Systeme Böblingen GmbH

Product code

Code DSA

Device class

Class 2

Regulation

21 CFR 870.2900

Advisory panel

Cardiovascular

Date received

2024-11-15

Decision date

2025-01-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Böblingen, DE

• K254114 — Baylis Connector Cable2026-01-18
• K252827 — IBP cable Becton Dickinson (2606488) +5 more2025-12-01
• K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m +8 more2025-09-30
• K242986 — SpO2 Extension Cable2025-05-02
• K240087 — RT Carbon ECG Leads2024-09-13

• K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)2026-05-29
• K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
• K251702 — IntelliVue Patient Monitor MX750 +2 more2025-11-10
• K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)2025-09-02
• K242962 — Telemetry Monitor 5500 Release 4.0 (867232)2025-05-05

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →