Clearance Summary
LIFEPAK® 35 AC Power Adapter (41335-000001) received FDA 510(k) clearance under submission number K240162, sponsored by Stryker Physio-Control. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-04-19.
- Submission: K240162
- Applicant / Sponsor: Stryker Physio-Control
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2024-04-19
Classification & Regulation
This clearance is catalogued under FDA product code MPD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.