MARION WINDOW— 510(k) K920182

Name: FDA 510(k) clearance K920182
Creator: U.S. Food and Drug Administration
Published: 1992-03-26

Substantially Equivalent

Tnt Moberg Intl. , Ltd.

FDA 510(k) clearance K920182 for MARION WINDOW, Substantially Equivalent on 1992-03-26. Applicant: Tnt Moberg Intl. , Ltd.. Device class: 1.

Clearance details

Applicant: Tnt Moberg Intl. , Ltd.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1992-01-15
Decision date: 1992-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.