M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
FDA 510(k) clearance K102495 · decided 2010-09-30
Clearance details
- K-number
- K102495
- Device name
- M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-08-31
- Decision date
- 2010-09-30
- Days to decision
- 30 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 |
|---|---|---|
| Philips Healthcare IntelliVue Info Center iX, A.0 866023 recall (Z-0856-2016) | Philips Electronics North America Corporation | 2016-02-23 |
| Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhy recall (Z-0857-2016) | Philips Electronics North America Corporation | 2016-02-23 |
| Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor ( recall (Z-0858-2016) | Philips Electronics North America Corporation | 2016-02-23 |
| Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by th recall (Z-0374-2016) | Philips Medical Systems, Inc. | 2015-12-04 |
| Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgra recall (Z-1783-2014) | Philips Healthcare Inc. | 2014-06-11 |
| Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX recall (Z-0495-2013) | Philips Healthcare Inc. | 2012-12-10 |
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 |