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FDA 510(k)

Transformair Indoor Air Purifier

K-Number: K161468 · 2017-02-08

ApplicantTransformair, LLC
Decision Date2017-02-08
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Transformair Indoor Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Transformair, LLC. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K161468. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transformair Indoor Air Purifier?

Transformair Indoor Air Purifier is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Transformair, LLC. The 510(k) number is K161468.

When did Transformair Indoor Air Purifier receive FDA 510(k) clearance?

Transformair Indoor Air Purifier received FDA 510(k) clearance on 2017-02-08, under 510(k) number K161468.

Who is the listed applicant for Transformair Indoor Air Purifier?

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

What is the FDA product code for Transformair Indoor Air Purifier?

The FDA product code for Transformair Indoor Air Purifier is FRA.

Related Devices (Code: FRA)

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.

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLCK232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle CorporationK221540Synexis Sphere RxSynexis, LLC

Official Source

View on FDA Database →

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

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