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510(k) K200500

Molekule Air Pro RX by Molekule, Inc. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2020
Date Received
February 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

Other clearances by Molekule, Inc.

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  • K202339 — Molekule Air Mini, Molekule Air Mini + (February 23, 2021)

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