Clearance Summary
AMER. EDWARDS LAB FLEXISCOPE received FDA 510(k) clearance under submission number K842410, sponsored by American Edwards Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-11-05.
- Submission: K842410
- Applicant / Sponsor: American Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4855
- Decision date: 1984-11-05
Classification & Regulation
This clearance is catalogued under FDA product code HRK and 21 CFR 886.4855, within the Ophthalmic review panel as a Class I device.