FDA 510(k)

유비 웨어러블 브라스틱 펌프 S1 (T8D02); 유비 웨어러블 브라스틱 펌프 E10 (T8D03)

K-번호: K250207 · 2025-08-11

결정일2025-08-11

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]

결정대체적으로 동일

기기 요약

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is the device name listed in this FDA 510(k) record. The listed applicant is Anker Innovations Limited. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K250207. 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 eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Anker Innovations Limited. The 510(k) number is K250207.

When did eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) receive FDA 510(k) clearance?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K250207.

Who is the listed applicant for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA 510(k) record lists Anker Innovations Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is HGX.

Anker Innovations Limited를 신청인으로 등재한 기타 기록

K254300유비 웨어러블 브라스틱 펌프 (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)

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