Cleared Traditional

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

K832371 · Electro-Med Health Industries, Inc. · Dental device
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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 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro-Med Health Industries, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -