Zoll R Series
FDA premarket approval P160022/S011 · decided 2019-08-09
Approval details
- PMA number
- P160022
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zoll R Series
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2019-05-13
- Decision date
- 2019-08-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for design changes to achieve compliance with EN 60601-1-2 (4th edition), PCB layout and parts changes, and minor mechanical changes to the speaker, printer, and display assemblies.
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