K827035Substantially Equivalent

Ocular Biometer 4000

Name: K827035 Ocular Biometer 4000
Creator: Radionics Medical, Inc.
Published: 1982-07-22
License: https://open.fda.gov/license/

Radionics Medical, Inc., Ontario L3r 1g2, CA / Traditional, Substantially Equivalent

FDA source

K827035 is the FDA 510(k) clearance record for OCULAR BIOMETER 4000, cleared for Radionics Medical, Inc. on 1982-07-22. FDA records list 5 510(k) clearances for Radionics Medical, Inc., from 1981-04-23 to 1985-04-18. As of 2026-09-10, FDA records show no recalls naming K827035.

Clearance record

Decision date: 1982-07-22
Received: 1982-04-23 (90 days to decision)
Review panel: Unknown
Applicant: Radionics Medical, Inc. 390 Steelcase Rd., E. Markham, Ontario L3r 1g2, CA
Third party review: No