X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
FDA premarket approval P160022 · decided 2017-12-27
Approval details
- PMA number
- P160022
- Trade name
- X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2016-07-07
- Decision date
- 2017-12-27
- Days to decision
- 538 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for the X Series Defibrillator Function. The X Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulseThe X Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The X Series system Semiautomatic
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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 |
| 731 Series Ventilators (K162832) | ZOLL Medical Corporation | 2017-08-02 |
| 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 |