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510(k) K230481

Evenflo Premium Double Electric Breast Pump (Model 4018) by Evenflo Feeding, Inc. — Product Code HGX

K230481 is an FDA 510(k) premarket notification submitted by Evenflo Feeding, Inc. for the device "Evenflo Premium Double Electric Breast Pump (Model 4018)". The FDA issued a decision of Substantially Equivalent on November 3, 2023. 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
November 3, 2023
Date Received
February 22, 2023
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

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FDA data resources