Clearance Summary
NARCOTREND, MODEL COMPACT 4.0 received FDA 510(k) clearance under submission number K033543, sponsored by Mt Monitortechnik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-09-17.
- Submission: K033543
- Applicant / Sponsor: Mt Monitortechnik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2004-09-17
Classification & Regulation
This clearance is catalogued under FDA product code OLW and 21 CFR 882.1400, within the Neurology review panel as a Class II device.