ZOLL RESCUENET 12-LEAD
FDA 510(k) clearance K121865 · decided 2012-11-20
Clearance details
- K-number
- K121865
- Device name
- ZOLL RESCUENET 12-LEAD
- Applicant
- ZOLL Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-06-26
- Decision date
- 2012-11-20
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chelsmford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OneStep CPR Complete Electrode (P160022/S049) | ZOLL Medical Corporation | 2025-12-30 |
| AED 3 (P160015/S025) | ZOLL Medical Corporation | 2025-12-18 |
| X Series®; Propaq MD®; AED 3 BLS; Zenix Professional Defibrillators (P160022/S046) | ZOLL Medical Corporation | 2025-12-18 |
| ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048) | ZOLL Medical Corporation | 2025-12-09 |
| ZOLL Zenix® Monitor/Defibrillator (P160022/S036) | ZOLL Medical Corporation | 2025-09-29 |
| CPR Uni-padz Electrode (P160022/S047) | ZOLL Medical Corporation | 2025-09-22 |
| CPR-D-padz Electrode (P160015/S026) | ZOLL Medical Corporation | 2025-09-22 |
| AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042) | ZOLL Medical Corporation | 2025-08-28 |