PMA P160022S006
- Device
- ZOLL R Series Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S006
- Product code
- MKJ
- Decision date
- 2018-09-03
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a change to the CPR algorithm and modified case upload capabilities.
Current openFDA PMA Record#
- Device
- ZOLL R Series Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S006
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-09-03
- Decision code
- APPR
- Date received
- 2018-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the CPR algorithm and modified case upload capabilities.