PMA P160022S012
- Device
- AED Pro Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S012
- Product code
- MKJ
- Decision date
- 2019-08-22
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Addition of a conformal coating and hipot test to the analog board, and updates to the system level testing.
Current openFDA PMA Record#
- Device
- AED Pro Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S012
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-08-22
- Decision code
- OK30
- Date received
- 2019-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a conformal coating and hipot test to the analog board, and updates to the system level testing.