INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
FDA 510(k) clearance K082633 · decided 2008-10-03
Clearance details
- K-number
- K082633
- Device name
- INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2008-09-10
- Decision date
- 2008-10-03
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DSI
- 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 |
|---|---|---|
| Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals recall (Z-2625-2010) | Philips Healthcare Inc. | 2010-09-29 |
| Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40 recall (Z-0817-2009) | Philips Medical Systems | 2009-01-13 |