K831406Substantially Equivalent

Restrospective ECG Memory Module

Name: K831406 Restrospective ECG Memory Module
Creator: Cardiac Evaluation Center, Inc.
Published: 1983-07-07
License: https://open.fda.gov/license/

Cardiac Evaluation Center, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K831406 is the FDA 510(k) clearance record for RESTROSPECTIVE ECG MEMORY MODULE, cleared for Cardiac Evaluation Center, Inc. on 1983-07-07. FDA records list 2 510(k) clearances for Cardiac Evaluation Center, Inc., from 1983-07-07 to 1996-07-11. As of 2026-09-10, FDA records show no recalls naming K831406.

Clearance record

Decision date: 1983-07-07
Received: 1983-05-02 (66 days to decision)
Review panel: Unknown
Applicant: Cardiac Evaluation Center, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No