PMA P160022S001
- Device
- ZOLL X Series
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2018-02-07
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a replacement FPGA component to address obsolescence of the current component.
Current openFDA PMA Record#
- Device
- ZOLL X Series
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-02-07
- Decision code
- APPR
- Date received
- 2018-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a replacement FPGA component to address obsolescence of the current component.