MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123— 510(k) K013027

Name: FDA 510(k) clearance K013027
Creator: U.S. Food and Drug Administration
Published: 2001-12-06

Substantially Equivalent

Respironics Healthscan, Inc.

FDA 510(k) clearance K013027 for MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123, Substantially Equivalent on 2001-12-06. Applicant: Respironics Healthscan, Inc.. Device class: 2.

Clearance details

Applicant: Respironics Healthscan, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 2001-09-10
Decision date: 2001-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.