PMA P160008S007
- Device
- HeartSine’s samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S007
- Product code
- MKJ
- Decision date
- 2019-11-19
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change of supplier for cable assemblies.
Current openFDA PMA Record#
- Device
- HeartSine’s samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S007
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-11-19
- Decision code
- OK30
- Date received
- 2019-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of supplier for cable assemblies.