K850868Substantially Equivalent

Mfe Cardiac Stress System

Name: K850868 Mfe Cardiac Stress System
Creator: Ketronic, Inc.
Published: 1985-06-12
License: https://open.fda.gov/license/

Ketronic, Inc., The Netherlands, NL / Traditional, Substantially Equivalent

FDA source

K850868 is the FDA 510(k) clearance record for MFE CARDIAC STRESS SYSTEM, cleared for Ketronic, Inc. on 1985-06-12. FDA records list 10 510(k) clearances for Ketronic, Inc., from 1984-11-08 to 1985-06-12. As of 2026-09-10, FDA records show no recalls naming K850868.

Clearance record

Decision date: 1985-06-12
Received: 1985-03-01 (103 days to decision)
Review panel: Unknown
Applicant: Ketronic, Inc. Duinkerkenlaan 31, The Netherlands, NL
Third party review: No