INTELLIVUE PATIENT MONITOR
FDA 510(k) clearance K122439 · decided 2012-08-29
Clearance details
- K-number
- K122439
- Device name
- INTELLIVUE PATIENT MONITOR
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2012-08-10
- Decision date
- 2012-08-29
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- MHX
- 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 MP20. Product Number: M8001A. recall (Z-0851-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue MP30. Product Number: M8002A. recall (Z-0852-2026) | Philips North America Llc | 2025-12-02 |
| Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8 recall (Z-0104-2015) | Philips Medical Systems, Inc. | 2014-10-21 |