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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 the device name listed in this FDA 510(k) record. The listed applicant is Molekule, Inc.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) 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. The listed applicant is Molekule, Inc.. The 510(k) number is K200500.

When did Molekule Air Pro RX receive FDA 510(k) clearance?

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

Who is the listed applicant for Molekule Air Pro RX?

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

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

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

Other records listing Molekule, Inc. as applicant

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.

K211194Molekule Air ProK202339Molekule Air Mini, Molekule Air Mini +

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

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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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