Zoll X Series Device (Oridion MicroMediCO2)
FDA premarket approval P160022/S004 · decided 2018-10-26
Approval details
- PMA number
- P160022
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zoll X Series Device (Oridion MicroMediCO2)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2018-05-18
- Decision date
- 2018-10-26
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for minor changes made within the C02 module that is incorporated into ZOLL's X Series device.
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