Molekule Air Pro

Purifier, Air, Ultraviolet, Medical

Molekule, Inc.

The following data is part of a premarket notification filed by Molekule, Inc. with the FDA for Molekule Air Pro.

Pre-market Notification Details

Device IDK211194
510k NumberK211194
Device Name:Molekule Air Pro
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant Molekule, Inc. 1301 Folsom St. San Francisco,  CA  94103
ContactFrank Bianco
CorrespondentAdrienne R. Lenz
Hymann, Phelps, & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington,  DC  20005
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-21
Decision Date2021-08-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00818701020353 K211194 000

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