Cleared Traditional

K840036 - FITEX
(FDA 510(k) Clearance)

Oct 1984
Decision
295d
Days
Risk

K840036 is an FDA 510(k) clearance for the FITEX..

Submitted by Britt Corp., Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 26, 1984, 295 days after receiving the submission on January 5, 1984.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K840036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date October 26, 1984
Days to Decision 295 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code
Device Class