FDA 510(k)

Wearable Electric Breast Pump (YM-8803)

K-번호: K252754 · 2025-12-19

신청자Guangdong Youmeng Electrical Technology Co., Ltd.

결정일2025-12-19

제품 코드HGX

자문 위원회OB

결정Substantially Equivalent

기기 요약

Wearable Electric Breast Pump (YM-8803) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252754. 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 Wearable Electric Breast Pump (YM-8803)?

Wearable Electric Breast Pump (YM-8803) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. The 510(k) number is K252754.

When did Wearable Electric Breast Pump (YM-8803) receive FDA 510(k) clearance?

Wearable Electric Breast Pump (YM-8803) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252754.

Who is the listed applicant for Wearable Electric Breast Pump (YM-8803)?

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

What is the FDA product code for Wearable Electric Breast Pump (YM-8803)?

The FDA product code for Wearable Electric Breast Pump (YM-8803) is HGX.

Guangdong Youmeng Electrical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))K252342Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)K232466Electric Breast Pump, model: YM-8166

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