HeartStart FRx Defibrillator
FDA premarket approval P180028/S003 · decided 2020-08-22
Approval details
- PMA number
- P180028
- Supplement
- S003
- 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
- 2020-07-31
- Decision date
- 2020-08-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Changes to the inspection procedures for components and subassemblies used to build the HeartStart family of defibrillators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |