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510(k) Data Aggregation

K Number

Device Name

HEPAIRX VENTILATING AIR PURIFIER

Manufacturer

AIR INNOVATIONS, INC.

Date Cleared

2013-01-23

(491 days)

Product Code

FRF

Regulation Number

880.5045

Why did this record match?

Applicant Name (Manufacturer) :

AIR INNOVATIONS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Filtering out airborne particulates from air for medical purposes. HEPAirX 100 is intended for over-the-counter use.

Device Description

Not Found

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