510(k) K210870

MEO Med Disposable Medical Face Mask by Fujian Meo Medical Technology Limited — Product Code FXX

K210870 is an FDA 510(k) premarket notification submitted by Fujian Meo Medical Technology Limited for the device "MEO Med Disposable Medical Face Mask". The FDA issued a decision of Substantially Equivalent on Jul 30, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 30, 2021
Date Received
Mar 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type
510(k)