PMA P160022S021
- Device
- AED 3 BLS
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S021
- Product code
- MKJ
- Decision date
- 2020-09-17
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- use of new Defibrillator Analyzers to measure the defibrillator energy output for the ZOLL AED 3 units
Current openFDA PMA Record#
- Device
- AED 3 BLS
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S021
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-09-17
- Decision code
- OK30
- Date received
- 2020-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- use of new Defibrillator Analyzers to measure the defibrillator energy output for the ZOLL AED 3 units