OSADA ENAC— 510(k) K844250

Name: FDA 510(k) clearance K844250
Creator: U.S. Food and Drug Administration
Published: 1985-01-23

Substantially Equivalent

Osada Electric Co., Ltd.

FDA 510(k) clearance K844250 for OSADA ENAC, Substantially Equivalent on 1985-01-23. Applicant: Osada Electric Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osada Electric Co., Ltd.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 1984-11-02
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.