INFANT/CHILD REDUCED ENERGY ELECTRODES
FDA 510(k) clearance K022732 · decided 2002-12-13
Clearance details
- K-number
- K022732
- Device name
- INFANT/CHILD REDUCED ENERGY ELECTRODES
- Applicant
- Medtronic Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-16
- Decision date
- 2002-12-13
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibri recall (Z-0186-2018) | Physio-Control, Inc. | 2017-12-12 |
| LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrilla recall (Z-0187-2018) | Physio-Control, Inc. | 2017-12-12 |