PMA P160022S011
- Device
- Zoll R Series
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S011
- Product code
- MKJ
- Decision date
- 2019-08-09
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order 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.
Current openFDA PMA Record#
- Device
- Zoll R Series
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S011
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-08-09
- Decision code
- APPR
- Date received
- 2019-05-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.