PULMONE MINIBOXPFT 2.0— 510(k) K141793

Name: FDA 510(k) clearance K141793
Creator: U.S. Food and Drug Administration
Published: 2015-03-06

Substantially Equivalent

Pulmone Advanced Medical Devices, Ltd.

FDA 510(k) clearance K141793 for PULMONE MINIBOXPFT 2.0, Substantially Equivalent on 2015-03-06. Applicant: Pulmone Advanced Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Pulmone Advanced Medical Devices, Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2014-07-02
Decision date: 2015-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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