Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Transformair, LLC. It received FDA 510(k) clearance on 2017-02-08 under approval 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. It is manufactured by Transformair, LLC. The 510(k) number is K161468.

When was Transformair Indoor Air Purifier approved by the FDA?

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

What company makes Transformair Indoor Air Purifier?

Transformair Indoor Air Purifier is manufactured by Transformair, LLC.

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)

K201220Aerus Medical Guardian,model F170AAerus Medical, LLC K200500Molekule Air Pro RXMolekule, Inc. K211139CUBE Air PurifierSamsung Electronics Co., Ltd. K211194Molekule Air ProMolekule, Inc. K202766EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd. K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc.

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.

↑