INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
FDA 510(k) clearance K131913 · decided 2013-11-26
Clearance details
- K-number
- K131913
- Device name
- INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2013-06-26
- Decision date
- 2013-11-26
- Days to decision
- 153 days
- Clearance type
- Abbreviated
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Bw, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 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 |