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510(k) K251977

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) by Ningbo Youhe Electrical Appliance Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2025
Date Received
June 27, 2025
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

Other clearances by Ningbo Youhe Electrical Appliance Technology Co., Ltd.

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  • K203148 — Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030) (July 8, 2021)
  • K163136 — Youha electric breast pump (July 31, 2017)

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