K852034Substantially Equivalent

Vitatron M

Name: K852034 Vitatron M
Creator: Elmed, Inc.
Published: 1986-01-03
License: https://open.fda.gov/license/

Elmed, Inc., Addison IL / Traditional, Substantially Equivalent

FDA source

K852034 is the FDA 510(k) clearance record for VITATRON M, cleared for Elmed, Inc. on 1986-01-03. FDA records list 15 510(k) clearances for Elmed, Inc., from 1986-01-03 to 2001-05-14. As of 2026-09-10, FDA records show no recalls naming K852034.

Clearance record

Decision date: 1986-01-03
Received: 1985-05-09 (239 days to decision)
Review panel: Unknown
Applicant: Elmed, Inc. 60 W. Fay Ave., Addison IL
Third party review: No