NEBU-SOL METERED DOSE DISPENSER (TM)— 510(k) K910239

Name: FDA 510(k) clearance K910239
Creator: U.S. Food and Drug Administration
Published: 1991-05-22

Substantially Equivalent

Dey Laboratories, Inc.

FDA 510(k) clearance K910239 for NEBU-SOL METERED DOSE DISPENSER (TM), Substantially Equivalent on 1991-05-22. Applicant: Dey Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dey Laboratories, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1991-01-22
Decision date: 1991-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Napa, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.