Clearance Summary
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K930023, sponsored by Welch Allyn, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-06-21.
- Submission: K930023
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1993-06-21
Classification & Regulation
This clearance is catalogued under FDA product code HLI and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.