Powerheart G5 Pediatric Electrodes
FDA premarket approval P160033/S006 · decided 2021-10-07
Approval details
- PMA number
- P160033
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Powerheart G5 Pediatric Electrodes
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2021-04-22
- Decision date
- 2021-10-07
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for a new supplier for the pediatric electrode for the Powerheart G5 Automated External Defibrillator.
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510(k) clearances by this applicant
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| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
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| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
| Power Infuser (K172653) | ZOLL Medical Corporation | 2018-07-18 |
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| Model 330 Multifunction Aspirator (K170533) | ZOLL Medical Corporation | 2017-04-18 |
| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |