INTELLIVUE MX40 PATIENT MONITOR
FDA 510(k) clearance K113125 · decided 2011-11-17
Clearance details
- K-number
- K113125
- Device name
- INTELLIVUE MX40 PATIENT MONITOR
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-10-24
- Decision date
- 2011-11-17
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- DSI
- 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 |
|---|---|---|
| Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expa recall (Z-0035-2025) | Philips North America | 2024-10-08 |
| IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Ce recall (Z-1746-2014) | Philips Medical Systems, Inc. | 2014-06-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator (861304) (P180028/S019) | Philips Medical Systems | 2026-05-21 |
| HeartStart FRx Defibrillator (P180028/S018) | Philips Medical Systems | 2026-02-02 |
| 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 |