FDA.reportPublic FDA data

510(k) K222702

Device
RGS; RGS Mini
Applicant
Genesis Air, Inc.
510(k) number
K222702
Product code
FRA
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-02
Date received
2022-09-07
Regulation
880.6500
Classification name
Purifier, Air, Ultraviolet, Medical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dan Briggs
Address
5202 County Rd. 7350, Suite D Lubbock TX US 79424 79424

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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