Cleared Traditional

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

Also includes:
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
K243545 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Jan 2025
Decision
63d
Days
Class 2
Risk

K243545 is an FDA 510(k) clearance for the Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).

Submitted by Philips Medizin Systeme B?blingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on January 17, 2025, 63 days after receiving the submission on November 15, 2024.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K243545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date January 17, 2025
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA - Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2900