PRESSIO ICP MONITORING SYSTEM
FDA 510(k) clearance K062584 · decided 2007-07-05
Clearance details
- K-number
- K062584
- Device name
- PRESSIO ICP MONITORING SYSTEM
- Applicant
- Sophysa SA
- Decision
- Substantially Equivalent
- Date received
- 2006-09-01
- Decision date
- 2007-07-05
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dana Point, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intende recall (Z-1825-2024) | Sophysa S.A. | 2024-05-15 |
| The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intende recall (Z-1826-2024) | Sophysa S.A. | 2024-05-15 |