Clearance Summary
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) received FDA 510(k) clearance under submission number K042742, sponsored by Heidelberg Engineering. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-10-13.
- Submission: K042742
- Applicant / Sponsor: Heidelberg Engineering
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2004-10-13
Classification & Regulation
This clearance is catalogued under FDA product code MXK and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.