PMA P160022S010
- Device
- X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S010
- Product code
- MKJ
- Decision date
- 2019-07-03
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for hardware and software changes to achieve compliance with an FDA-recognized consensus standard for electromagnetic compatibility.
Current openFDA PMA Record#
- Device
- X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S010
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-07-03
- Decision code
- APPR
- Date received
- 2019-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware and software changes to achieve compliance with an FDA-recognized consensus standard for electromagnetic compatibility.