Clearance Summary
JANUS ATAC ENG ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K904385, sponsored by Life-Tech Intl., 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 1992-06-10.
- Submission: K904385
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1460
- Decision date: 1992-06-10
Classification & Regulation
This clearance is catalogued under FDA product code GWN and 21 CFR 882.1460, within the Neurology review panel as a Class II device.