510(k) K130529
K130529 is an FDA 510(k) premarket notification submitted by Raumedic AG for the device "RAUMEDIC-PTO-MONITORING-SYSTEM". The FDA issued a decision of Substantially Equivalent on October 25, 2013. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Raumedic AG has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2013
- Date Received
- March 1, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Device, Monitoring, Intracranial Pressure
- Device Class
- Class II
- Regulation Number
- 882.1620
- Review Panel
- NE
- Submission Type