PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
FDA 510(k) clearance K020055 · decided 2002-03-15
Clearance details
- K-number
- K020055
- Device name
- PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-01-08
- Decision date
- 2002-03-15
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AD5 table for use with Integris and Integris Allura x-ray systems recall (Z-0206-06) | Philips Medical Systems North America Co. Phillips | 2005-11-29 |
| AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt ver recall (Z-0207-06) | Philips Medical Systems North America Co. Phillips | 2005-11-29 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
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| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
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