Clearance Summary
CAPNOCHECK II, MODEL 8400 received FDA 510(k) clearance under submission number K991086, sponsored by Bci Intl., 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 1999-06-09.
- Submission: K991086
- Applicant / Sponsor: Bci Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1999-06-09
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.