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510(k) K203189

AEROCURE-MD by Aerobiotix, Inc. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2021
Date Received
October 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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