HeartStart FRx Defibrillator
FDA premarket approval P180028/S004 · decided 2020-12-16
Approval details
- PMA number
- P180028
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartStart FRx Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Philips Medical Systems
- Date received
- 2020-11-16
- Decision date
- 2020-12-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- updates to the inspection process for various device components and sub-assemblies
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510(k) clearances by this applicant
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|---|---|---|
| Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System (K212704) | Philips Medical Systems | 2021-09-24 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K211597) | Philips Medical Systems | 2021-09-08 |
| Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (K210560) | Philips Medical Systems | 2021-06-30 |
| PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (K191738) | Philips Medical Systems | 2020-09-29 |
| Philips Biosensor BX100 (K192875) | Philips Medical Systems | 2020-04-16 |
| M3290B Patient Information Center iX (K183387) | Philips Medical Systems | 2019-08-06 |
| MX40 Release C.01 (K180017) | Philips Medical Systems | 2018-07-24 |
| MX40 Release B.07 (K172226) | Philips Medical Systems | 2017-11-09 |