PMA P160022S056
- Device
- ZOLL R Series Monitor/Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S056
- Product code
- MKJ
- Decision date
- 2026-10-16
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- an alternate critical component on the printed circuit board assembly
Current openFDA PMA Record#
- Device
- ZOLL R Series Monitor/Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S056
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-10-16
- Decision code
- OK30
- Date received
- 2026-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate critical component on the printed circuit board assembly