HIGHPAK-12
FDA 510(k) clearance K062331 · decided 2007-07-10
Clearance details
- K-number
- K062331
- Device name
- HIGHPAK-12
- Applicant
- Ad Elektronik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2006-08-10
- Decision date
- 2007-07-10
- Days to decision
- 334 days
- Clearance type
- Traditional
- Product code
- MPD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lutsen, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| LIFEPAK® 35 AC Power Adapter (41335-000001) (K240162) | Stryker Physio-Control | 2024-04-19 |
Recalls involving this device
No recalls on record reference this clearance.