Clearance Summary
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 received FDA 510(k) clearance under submission number K974467, sponsored by Aesculap-Meditec North America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-02-19.
- Submission: K974467
- Applicant / Sponsor: Aesculap-Meditec North America
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1998-02-19
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.