Clearance Summary
MEDITEC LINK received FDA 510(k) clearance under submission number K981196, 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 1998-06-17.
- Submission: K981196
- Applicant / Sponsor: Aesculap-Meditec North America
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 1998-06-17
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.