Zoll X Series Device
FDA premarket approval P160022/S005 · decided 2018-08-03
Approval details
- PMA number
- P160022
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zoll X Series Device
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2018-06-07
- Decision date
- 2018-08-03
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for introducing the following three new software features to the ZOLL X Series device: readiness test, AutoPulse recognition, and ResQPUMP recognition.
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