ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055— 510(k) K003423

Name: FDA 510(k) clearance K003423
Creator: U.S. Food and Drug Administration
Published: 2001-02-22

Substantially Equivalent

St. Francis Medical Equipment Co., Ltd.

FDA 510(k) clearance K003423 for ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055, Substantially Equivalent on 2001-02-22. Applicant: St. Francis Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: St. Francis Medical Equipment Co., Ltd.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2000-11-03
Decision date: 2001-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Shien, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.