510(k) K253099
K253099 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "LIFEPAK 15 AC Power Adapter (41577-000333)". The FDA issued a decision of Substantially Equivalent on October 14, 2025. 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. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2025
- Date Received
- September 24, 2025
- Clearance Type
- Special
- 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