510(k) K801755
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- July 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Monitoring, Intracranial Pressure
- Device Class
- Class II
- Regulation Number
- 882.1620
- Review Panel
- NE
- Submission Type