Clearance Summary
A O MICROSCOPE VIDEO SYSTEM received FDA 510(k) clearance under submission number K821865, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1982-07-14.
- Submission: K821865
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3600
- Decision date: 1982-07-14
Classification & Regulation
This clearance is catalogued under FDA product code IBJ and 21 CFR 864.3600, within the Pathology review panel as a Class I device.