SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050— 510(k) K002468

Name: FDA 510(k) clearance K002468
Creator: U.S. Food and Drug Administration
Published: 2001-03-02

Substantially Equivalent

San UP S.A.

FDA 510(k) clearance K002468 for SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050, Substantially Equivalent on 2001-03-02. Applicant: San UP S.A.. Device class: 2.

Clearance details

Applicant: San UP S.A.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 2000-08-11
Decision date: 2001-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.