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FDA 510(k)

Molekule Air Pro

K-Number: K211194 · 2021-08-20

ApplicantMolekule, Inc.
Decision Date2021-08-20
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Molekule Air Pro is a medical device manufactured by Molekule, Inc.. It received FDA 510(k) clearance on 2021-08-20 under approval number K211194. 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 Molekule Air Pro?

Molekule Air Pro is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Molekule, Inc.. The 510(k) number is K211194.

When was Molekule Air Pro approved by the FDA?

Molekule Air Pro received FDA 510(k) clearance on 2021-08-20, under approval number K211194.

What company makes Molekule Air Pro?

Molekule Air Pro is manufactured by Molekule, Inc..

What is the FDA product code for Molekule Air Pro?

The FDA product code for Molekule Air Pro is FRA.

Other Devices by Molekule, Inc.

K200500Molekule Air Pro RX K202339Molekule Air Mini, Molekule Air Mini +

Related Devices (Code: FRA)

K161468Transformair Indoor Air PurifierTransformair, LLC K201220Aerus Medical Guardian,model F170AAerus Medical, LLC K200500Molekule Air Pro RXMolekule, Inc. K211139CUBE Air PurifierSamsung Electronics Co., Ltd. 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.

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