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510(k) K191802

Electric Breast Pump by Ningbo Huiyoo Baby Products Co., Ltd. — Product Code HGX

K191802 is an FDA 510(k) premarket notification submitted by Ningbo Huiyoo Baby Products Co., Ltd. for the device "Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on Jan 16, 2020. 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
Jan 16, 2020
Date Received
Jul 3, 2019
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