BREEZE NEBULIZER (NBR-10X)— 510(k) K133105

Name: FDA 510(k) clearance K133105
Creator: U.S. Food and Drug Administration
Published: 2014-06-24

Substantially Equivalent

Digio2 International Co., Ltd.

FDA 510(k) clearance K133105 for BREEZE NEBULIZER (NBR-10X), Substantially Equivalent on 2014-06-24. Applicant: Digio2 International Co., Ltd.. Device class: 2.

Clearance details

Applicant: Digio2 International Co., Ltd.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2013-09-30
Decision date: 2014-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.