NEONATAL UNILET— 510(k) K861243

Substantially Equivalent

Ulster Scientific, Inc.

FDA 510(k) clearance K861243 for NEONATAL UNILET, Substantially Equivalent on 1986-04-29. Applicant: Ulster Scientific, Inc..

Clearance details

Applicant: Ulster Scientific, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1986-04-02
Decision date: 1986-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highland, NY, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.