Data / Medical devices / United States / Lung Assist Ii Inc

Lung Assist Ii Inc: FDA-registered device maker in Boulder, CO, United States, 1 510(k) clearance

Lung Assist Ii Inc is registered with the FDA (registration 3025936435) in Boulder, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 1980. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3025936435

Address

4655 Kirkwood Court, Boulder, CO, United States, 80301

Owner or operator

Lung Assist II Inc (10087122)

Roles

Specification developer

First device listed

January 14, 2023

Registered through

2026

Brand names listed

Exsufflation Belt

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated May 28, 1980. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.