Clearance Summary
MGA 2000 GAS ANALYSER received FDA 510(k) clearance under submission number K854076, sponsored by Airspec , Ltd.. 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 1985-12-11.
- Submission: K854076
- Applicant / Sponsor: Airspec , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2860
- Decision date: 1985-12-11
Classification & Regulation
This clearance is catalogued under FDA product code DOP and 21 CFR 862.2860, within the Clinical Chemistry review panel as a Class I device.