510(k) K060963
K060963 is an FDA 510(k) premarket notification submitted by Twin Star Medical for the device "TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)". The FDA issued a decision of Substantially Equivalent on June 6, 2006. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. Twin Star Medical has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2006
- Date Received
- April 7, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Pressure, Intracompartmental
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type