Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
The Auxiliary Power Supply (AC or DC) for Low-Energy DC Defibrillators is a cardiovascular accessory device that provides alternative power to low-energy direct-current defibrillators, ensuring uninterrupted operation in emergency situations. Classified as FDA Class 2 under 21 CFR 870.5300 in the Cardiovascular specialty, it requires 510(k) premarket notification. The product code is MPD, and it carries a life-sustaining support flag due to its role in supporting defibrillator operation.
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Basic Information
- Product Code
- MPD
- Device Class
- FDA class 2
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Oct 14, 2025 | Substantially Equivalent | Physio-Control, Inc. |
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Apr 19, 2024 | Substantially Equivalent | Stryker Physio-Control |
| K062331 | HIGHPAK-12 | Jul 10, 2007 | Substantially Equivalent | Ad Elektronik GmbH |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.