Clearance Summary
MILLER/NADLER GLARE TESTER received FDA 510(k) clearance under submission number K812706, sponsored by Mosebach Electric & Supply. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1981-11-16.
- Submission: K812706
- Applicant / Sponsor: Mosebach Electric & Supply
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1680
- Decision date: 1981-11-16
Classification & Regulation
This clearance is catalogued under FDA product code HOS and 21 CFR 886.1680, within the Ophthalmic review panel as a Class I device.