Clearance Summary
MINI-LOGGER SERIES 2000 received FDA 510(k) clearance under submission number K991045, sponsored by Mini-Mitter Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-09-21.
- Submission: K991045
- Applicant / Sponsor: Mini-Mitter Co., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1999-09-21
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.