PULMODYNE CHF FLOW GENERATOR SYSTEM— 510(k) K080256

Name: FDA 510(k) clearance K080256
Creator: U.S. Food and Drug Administration
Published: 2008-05-09

Substantially Equivalent

Pulmodyne

FDA 510(k) clearance K080256 for PULMODYNE CHF FLOW GENERATOR SYSTEM, Substantially Equivalent on 2008-05-09. Applicant: Pulmodyne. Device class: 2.

Clearance details

Applicant: Pulmodyne
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 2008-01-31
Decision date: 2008-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.