PMA P160022S027
- Device
- X Series, R Series, Propaq MD, and AED Pro
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S027
- Product code
- MKJ
- Decision date
- 2021-03-26
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Introduction of a new Automatic Optical Inspection (AOI) machine used during PCBA manufacturing at the supplier.
Current openFDA PMA Record#
- Device
- X Series, R Series, Propaq MD, and AED Pro
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S027
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-03-26
- Decision code
- OK30
- Date received
- 2021-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a new Automatic Optical Inspection (AOI) machine used during PCBA manufacturing at the supplier.