INTEGRA LICOX PTO2 MONITOR
FDA 510(k) clearance K131184 · decided 2013-08-30
Clearance details
- K-number
- K131184
- Device name
- INTEGRA LICOX PTO2 MONITOR
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-25
- Decision date
- 2013-08-30
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Tempera recall (Z-1618-2015) | Integra LifeSciences Corp. | 2015-05-15 |
| The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Tempera recall (Z-1619-2015) | Integra LifeSciences Corp. | 2015-05-15 |
| The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Tempera recall (Z-1620-2015) | Integra LifeSciences Corp. | 2015-05-15 |
| Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, recall (Z-0201-2015) | Integra LifeSciences Corp. | 2014-11-10 |
| Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and recall (Z-1675-2014) | Integra LifeSciences Corp. | 2014-05-30 |