Clearance Summary
ELECTRONIC SPIROMETER MODEL MFR-8100 received FDA 510(k) clearance under submission number K810712, sponsored by Nihon Kohden America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1981-03-24.
- Submission: K810712
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 1981-03-24
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.