VITAL COUGH— 510(k) K132988

Substantially Equivalent

Lung Assist, Inc.

FDA 510(k) clearance K132988 for VITAL COUGH, Substantially Equivalent on 2014-03-28. Applicant: Lung Assist, Inc..

Clearance details

Applicant: Lung Assist, Inc.
Product code: Code NHJ
Advisory panel: Anesthesiology
Date received: 2013-09-24
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.