510(k) K240162
K240162 is an FDA 510(k) premarket notification submitted by Stryker Physio-Control for the device "LIFEPAK® 35 AC Power Adapter (41335-000001)". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code MPD (Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator), a Class II device regulated under 21 CFR 870.5300. Stryker Physio-Control has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2024
- Date Received
- January 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type