UNIVERSAL-ERGOTEST— 510(k) K843850

Name: FDA 510(k) clearance K843850
Creator: U.S. Food and Drug Administration
Published: 1984-11-27

Substantially Equivalent

Erich Jaeger, Inc.

FDA 510(k) clearance K843850 for UNIVERSAL-ERGOTEST, Substantially Equivalent on 1984-11-27. Applicant: Erich Jaeger, Inc.. Device class: 2.

Clearance details

Applicant: Erich Jaeger, Inc.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1984-10-01
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.