IntelliVue Patient Monitor
FDA 510(k) clearance K151681 · decided 2015-07-17
Clearance details
- K-number
- K151681
- Device name
- IntelliVue Patient Monitor
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-06-22
- Decision date
- 2015-07-17
- Days to decision
- 25 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 MP40. Product Number: M8003A. recall (Z-0853-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP50. Product Number: M8004A. recall (Z-0854-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP60. Product Number: M8005A. recall (Z-0855-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP70. Product Number: M8007A. recall (Z-0856-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP80. Product Number: M8008A. recall (Z-0857-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP90. Product Number: M8010A. recall (Z-0858-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue G7m Anesthesia Gas Module, Product Number 866173 recall (Z-0007-2025) | Philips North America | 2024-10-01 |