Cleared Traditional

ERGO DIAGNOSTIC CARD (K834145) - FDA 510(k) Clearance

Class I Ophthalmic device.

K834145 · American Ergo Systems · Ophthalmic device
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Mar 1984
Decision
106d
Days
Class 1
Risk

K834145 is an FDA 510(k) clearance for the ERGO DIAGNOSTIC CARD. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by American Ergo Systems (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all American Ergo Systems devices

Submission Details

510(k) Number K834145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 16, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.