PMA P170018S003
- Device
- LIFEPAK CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S003
- Product code
- MKJ
- Decision date
- 2019-05-02
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for use of an alternate high-voltage capacitor from an alternate supplier.
Current openFDA PMA Record#
- Device
- LIFEPAK CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S003
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-05-02
- Decision code
- APPR
- Date received
- 2019-01-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of an alternate high-voltage capacitor from an alternate supplier.