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510(k) K170722

Moxxly Flow Collection System by Moxxly, Inc. — Product Code HGX

K170722 is an FDA 510(k) premarket notification submitted by Moxxly, Inc. for the device "Moxxly Flow Collection System". The FDA issued a decision of Substantially Equivalent on Aug 28, 2017. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 28, 2017
Date Received
Mar 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

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FDA data resources