MODEL #5000 PULMO PLUS— 510(k) K946039

Name: FDA 510(k) clearance K946039
Creator: U.S. Food and Drug Administration
Published: 1995-06-16

Substantially Equivalent

International Medical Systems

FDA 510(k) clearance K946039 for MODEL #5000 PULMO PLUS, Substantially Equivalent on 1995-06-16. Applicant: International Medical Systems. Device class: 2.

Clearance details

Applicant: International Medical Systems
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1994-12-12
Decision date: 1995-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Des Molnes, IA, 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.