AEROSOL ONE, NEBULIZER PUMP— 510(k) K870428

Name: FDA 510(k) clearance K870428
Creator: U.S. Food and Drug Administration
Published: 1987-05-15

Substantially Equivalent

Ashai Co. , Ltd.

FDA 510(k) clearance K870428 for AEROSOL ONE, NEBULIZER PUMP, Substantially Equivalent on 1987-05-15. Applicant: Ashai Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Ashai Co. , Ltd.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1987-02-03
Decision date: 1987-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

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.