HeartStart FRx Defibrillator (861304)
FDA premarket approval P180028/S010 · decided 2021-09-24
Approval details
- PMA number
- P180028
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartStart FRx Defibrillator (861304)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Philips Medical Systems
- Date received
- 2021-08-30
- Decision date
- 2021-09-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Change to the hardliner sealing process for the SMART Padz II.
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510(k) clearances by this applicant
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