Cleared Traditional

K832371 - EGS MODEL 300
(FDA 510(k) Clearance)

Oct 1983
Decision
80d
Days
Risk

K832371 is an FDA 510(k) clearance for the EGS MODEL 300..

Submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1983, 80 days after receiving the submission on July 18, 1983.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K832371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date October 06, 1983
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code
Device Class