UNIVERSAL-ERGOTEST— 510(k) K843850

Substantially Equivalent

Erich Jaeger, Inc.

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

Clearance details

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

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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.