Philips Reusable ECG Lead Sets and Trunk Cables : Model Number - 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC

by Philips Medizin Systeme Böblingen GmbH

510(k) K243545

Listed No authorization on record

Valid until

Not applicable

No authorization on record

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Not checked

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Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number: K243545
FDA Product Code: DSA
Models / Variants: 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

Device Class: Class II
Regulation: 21 CFR Part 870.2900
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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