NEBULIZER SYSTEM— 510(k) K922623

Name: FDA 510(k) clearance K922623
Creator: U.S. Food and Drug Administration
Published: 1992-12-01

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K922623 for NEBULIZER SYSTEM, Substantially Equivalent on 1992-12-01. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1992-06-02
Decision date: 1992-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.