COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
FDA 510(k) clearance K962928 · decided 1996-12-20
Clearance details
- K-number
- K962928
- Device name
- COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
- Applicant
- Camino Neurocare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-29
- Decision date
- 1996-12-20
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 3 recall (Z-0602-2014) | Integra LifeSciences Corp. | 2013-12-27 |
| Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors recall (Z-0944-2012) | Integra LifeSciences Corp | 2012-02-03 |