Clearance Summary
CANON 60 DEGREE FUNDUS CAMERA CF-60S received FDA 510(k) clearance under submission number K844053, sponsored by Canon USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1984-12-19.
- Submission: K844053
- Applicant / Sponsor: Canon USA, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1984-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HFI and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.