FDA 510(k)

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

K-번호: K251977 · 2025-10-22

신청자Ningbo Youhe Electrical Appliance Technology Co., Ltd.

결정일2025-10-22

제품 코드HGX

자문 위원회의료장비 규제 텍스트 번역 [기업명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

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기기 요약

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) 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 2025-10-22 under 510(k) number K251977. 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 electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K251977.

When did electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) receive FDA 510(k) clearance?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251977.

Who is the listed applicant for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

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 electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

The FDA product code for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is HGX.

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

K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)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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