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FDA 510(k)

HEPAIRX VENTILATING AIR PURIFIER

K-Number: K112728 · 2013-01-23

ApplicantAir Innovations, Inc.
Decision Date2013-01-23
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEPAIRX VENTILATING AIR PURIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Air Innovations, Inc.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K112728. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPAIRX VENTILATING AIR PURIFIER?

HEPAIRX VENTILATING AIR PURIFIER is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Air Innovations, Inc.. The 510(k) number is K112728.

When did HEPAIRX VENTILATING AIR PURIFIER receive FDA 510(k) clearance?

HEPAIRX VENTILATING AIR PURIFIER received FDA 510(k) clearance on 2013-01-23, under 510(k) number K112728.

Who is the listed applicant for HEPAIRX VENTILATING AIR PURIFIER?

The FDA 510(k) record lists Air Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEPAIRX VENTILATING AIR PURIFIER?

The FDA product code for HEPAIRX VENTILATING AIR PURIFIER is FRF.

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Related Devices (Code: FRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251872Biomoneta Avata RxBiomoneta Research Private LimitedK242102CerroZone MiniCerrozone, LLCK240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd.K223835MA-40, MA-112Medify Air, LLCK222416RIA SafeguardRia Tech Co., Ltd.K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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