Clearance Summary
F110 PHOTO BINOCULAR OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K802351, sponsored by Minami, Tomine & Lew. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-12-17.
- Submission: K802351
- Applicant / Sponsor: Minami, Tomine & Lew
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1700
- Decision date: 1980-12-17
Classification & Regulation
This clearance is catalogued under FDA product code HLG and 21 CFR 886.1700, within the Ophthalmic review panel as a Class I device.