MiniBox +— 510(k) K161295

Name: FDA 510(k) clearance K161295
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Substantially Equivalent

Pulmone Advanced Medical Devices, Ltd.

FDA 510(k) clearance K161295 for MiniBox +, Substantially Equivalent on 2016-10-21. Applicant: Pulmone Advanced Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Pulmone Advanced Medical Devices, Ltd.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2016-05-09
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: RaAnanna, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.