FDA 510(k)

스마트 양면 착용 유산물 펌프, 전기 양면 유산물 펌프

K-번호: K230102 · 2023-09-21

신청자Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

결정일2023-09-21

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

Smart double sides wearable breast pump, Electric bilateral breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230102. 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 Smart double sides wearable breast pump, Electric bilateral breast pump?

Smart double sides wearable breast pump, Electric bilateral breast pump is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K230102.

When did Smart double sides wearable breast pump, Electric bilateral breast pump receive FDA 510(k) clearance?

Smart double sides wearable breast pump, Electric bilateral breast pump received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230102.

Who is the listed applicant for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA 510(k) record lists Huizhou Lvb Maternal and Infant Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump is HGX.

Huizhou Lvb Maternal and Infant Supplies Co., Ltd.를 신청인으로 등재한 기타 기록

K252192가상유두 펌프(가상유두 펌프 P9, P10, P16, P20, P21, P22, P23, P25)K241004가상유두 펌프(ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

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