Clearance Summary
BC 900 SLIT LAMP received FDA 510(k) clearance under submission number K982057, sponsored by Haag-Streit AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-08-14.
- Submission: K982057
- Applicant / Sponsor: Haag-Streit AG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1998-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.