PMA P160022S017
- Device
- ZOLL R Series
- Applicant
- ZOLL Medical Corporation
- Product code
- MKJ
- Decision date
- 2020-07-07
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a new software release, MCU 19, for the R Series device.
Current openFDA PMA Record#
- Device
- ZOLL R Series
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S017
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-07-07
- Decision code
- APPR
- Date received
- 2020-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new software release, MCU 19, for the R Series device.