INTEGRA CAMINO ICP MONITOR
FDA 510(k) clearance K121573 · decided 2012-09-10
Clearance details
- K-number
- K121573
- Device name
- INTEGRA CAMINO ICP MONITOR
- Applicant
- Intrgra Lifesciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-05-29
- Decision date
- 2012-09-10
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, 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 |