FDA 510(k)

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

K-번호: K242725 · 2025-05-30

신청자Ningbo Youhe Electrical Appliance Technology Co., Ltd.

결정일2025-05-30

제품 코드HGX

자문 위원회OB

결정Substantially Equivalent

기기 요약

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242725. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K242725.

When did Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) receive FDA 510(k) clearance?

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242725.

Who is the listed applicant for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

The FDA 510(k) record lists Ningbo Youhe Electrical Appliance Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

The FDA product code for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is HGX.

Ningbo Youhe Electrical Appliance Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)K163136Youha electric breast pump

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