VIGORMIST COMPRESSOR NEBULIZER— 510(k) K031413

Substantially Equivalent

Vega Technologies, Inc.

FDA 510(k) clearance K031413 for VIGORMIST COMPRESSOR NEBULIZER, Substantially Equivalent on 2003-10-07. Applicant: Vega Technologies, Inc..

Clearance details

Applicant: Vega Technologies, Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 2003-05-05
Decision date: 2003-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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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.