Clearance Summary
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM received FDA 510(k) clearance under submission number K102077, sponsored by Cma Microdialysis AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-01-14.
- Submission: K102077
- Applicant / Sponsor: Cma Microdialysis AB
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2011-01-14
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.