Clearance Summary
MASSTRON/MARQUEST MT-1000 GAS ANALYZER received FDA 510(k) clearance under submission number K871253, sponsored by Masstron C/O Burditt, Bowles & Radzius, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1987-06-15.
- Submission: K871253
- Applicant / Sponsor: Masstron C/O Burditt, Bowles & Radzius, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1987-06-15
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.