Molekule Air Mini, Molekule Air Mini +— 510(k) K202339

Name: FDA 510(k) clearance K202339
Creator: U.S. Food and Drug Administration
Published: 2021-02-23

Substantially Equivalent

Molekule, Inc.

FDA 510(k) clearance K202339 for Molekule Air Mini, Molekule Air Mini +, Substantially Equivalent on 2021-02-23. Applicant: Molekule, Inc.. Device class: 2.

Clearance details

Applicant: Molekule, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2020-08-17
Decision date: 2021-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.