Cleared Traditional

K832370 - EGS MODEL 100-2
(FDA 510(k) Clearance)

Sep 1983
Decision
60d
Days
Risk

K832370 is an FDA 510(k) clearance for the EGS MODEL 100-2..

Submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1983, 60 days after receiving the submission on July 18, 1983.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K832370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date September 16, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code
Device Class