Cleared Traditional

LIFEPAK? 35 AC Power Adapter (41335-000001)

K240162 · Stryker Physio-Control · Cardiovascular
Apr 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K240162 is an FDA 510(k) clearance for the LIFEPAK? 35 AC Power Adapter (41335-000001), a Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator (Class II — Special Controls, product code MPD), submitted by Stryker Physio-Control (Redmond, US). The FDA issued a Cleared decision on April 19, 2024, 88 days after receiving the submission on January 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K240162 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2024
Decision Date April 19, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MPD — Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300