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FDA 510(k)

Molekule Air Pro RX

K-Number: K200500 · 2020-04-15

ApplicantMolekule, Inc.
Decision Date2020-04-15
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Molekule Air Pro RX is a medical device manufactured by Molekule, Inc.. It received FDA 510(k) clearance on 2020-04-15 under approval number K200500. 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 RX?

Molekule Air Pro RX is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Molekule, Inc.. The 510(k) number is K200500.

When was Molekule Air Pro RX approved by the FDA?

Molekule Air Pro RX received FDA 510(k) clearance on 2020-04-15, under approval number K200500.

What company makes Molekule Air Pro RX?

Molekule Air Pro RX is manufactured by Molekule, Inc..

What is the FDA product code for Molekule Air Pro RX?

The FDA product code for Molekule Air Pro RX is FRA.

Other Devices by Molekule, Inc.

K211194Molekule Air Pro K202339Molekule Air Mini, Molekule Air Mini +

Related Devices (Code: FRA)

K161468Transformair Indoor Air PurifierTransformair, LLC K201220Aerus Medical Guardian,model F170AAerus Medical, LLC 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.

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