RGS; RGS Mini— 510(k) K222702

Substantially Equivalent

Genesis Air, Inc.

FDA 510(k) clearance K222702 for RGS; RGS Mini, Substantially Equivalent on 2023-06-02. Applicant: Genesis Air, Inc.. Device class: 2.

Clearance details

Applicant: Genesis Air, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2022-09-07
Decision date: 2023-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

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