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510(k) K211194

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
April 21, 2021
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.

  • K202339 — Molekule Air Mini, Molekule Air Mini + (February 23, 2021)
  • K200500 — Molekule Air Pro RX (April 15, 2020)

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