Clearance Summary
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS received FDA 510(k) clearance under submission number K850360, sponsored by Text Tech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1985-04-17.
- Submission: K850360
- Applicant / Sponsor: Text Tech Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1120
- Decision date: 1985-04-17
Classification & Regulation
This clearance is catalogued under FDA product code CHL and 21 CFR 862.1120, within the Clinical Chemistry review panel as a Class II device.