M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
FDA 510(k) clearance K062271 · decided 2006-11-30
Clearance details
- K-number
- K062271
- Device name
- M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2006-08-07
- Decision date
- 2006-11-30
- Days to decision
- 115 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 8 recall (Z-2528-2017) | Philips Electronics North America Corporation | 2017-06-13 |
| Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivu recall (Z-0451-2008) | Philips Medical Systems | 2007-12-11 |
| Intellivue Central Station Software for the: Intellivue Information Center; Philips Inform recall (Z-1182-2007) | Philips Medical Systems | 2007-09-05 |
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 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| 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 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |