FDA 510(k)

Molekule Air Pro

K-Number: K211194 · 2021-08-20

Decision Date2021-08-20

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Molekule Air Pro is the device name listed in this FDA 510(k) record. The listed applicant is Molekule, Inc.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) 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. The listed applicant is Molekule, Inc.. The 510(k) number is K211194.

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

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

Who is the listed applicant for Molekule Air Pro?

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?

The FDA product code for Molekule Air Pro 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.

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

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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.