510(k) K844214
K844214 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "COMPARTMENT SYNDROME PRESSURE MONITOR SYS". The FDA issued a decision of Substantially Equivalent on April 4, 1985. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1985
- Date Received
- October 31, 1984
- 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