IntelliVue Patient Monitor
FDA 510(k) clearance K150310 · decided 2015-05-13
Clearance details
- K-number
- K150310
- Device name
- IntelliVue Patient Monitor
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-02-09
- Decision date
- 2015-05-13
- Days to decision
- 93 days
- Clearance type
- Special
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliVue MP2. Product Number: M8102A. recall (Z-0849-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP5. Product Number: M8105A. recall (Z-0850-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Multi Measurement Server X2. Product Number: M3002A. recall (Z-0859-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX600. Product Number: 865242. recall (Z-0866-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX700. Product Number: 865241. recall (Z-0867-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX800. Product Number: 865240. recall (Z-0869-2026) | Philips North America Llc | 2025-12-02 |