LIFEPAK® 35 AC Power Adapter (41335-000001)
FDA 510(k) clearance K240162 · decided 2024-04-19
Clearance details
- K-number
- K240162
- Device name
- LIFEPAK® 35 AC Power Adapter (41335-000001)
- Applicant
- Stryker Physio-Control
- Decision
- Substantially Equivalent
- Date received
- 2024-01-22
- Decision date
- 2024-04-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MPD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| HIGHPAK-12 (K062331) | Ad Elektronik GmbH | 2007-07-10 |
Recalls involving this device
No recalls on record reference this clearance.