INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
FDA 510(k) clearance K082583 · decided 2009-02-25
Clearance details
- K-number
- K082583
- Device name
- INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2008-09-08
- Decision date
- 2009-02-25
- Days to decision
- 170 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliBridge EC10 Module. Model Number: 865115 recall (Z-1106-2025) | Philips North America Llc | 2025-02-05 |
| IntelliVue Patient Monitor MX400. Model Number: 866060 recall (Z-1107-2025) | Philips North America Llc | 2025-02-05 |
| IntelliVue Patient Monitor MX450. Model Number: 866062 recall (Z-1108-2025) | Philips North America Llc | 2025-02-05 |
| IntelliVue Patient Monitor MX500. Model Number: 866064 recall (Z-1109-2025) | Philips North America Llc | 2025-02-05 |
| IntelliVue Patient Monitor MX550. Model Number: 866066 recall (Z-1110-2025) | Philips North America Llc | 2025-02-05 |