Molekule Air Pro— 510(k) K211194

Substantially Equivalent

Molekule, Inc.

FDA 510(k) clearance K211194 for Molekule Air Pro, Substantially Equivalent on 2021-08-20. 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: 2021-04-21
Decision date: 2021-08-20
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.