FDA 510(k)

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

K-Nummer: K252342 · 2025-12-19

AntragstellerGuangdong Youmeng Electrical Technology Co., Ltd.

Entscheidungsdatum2025-12-19

ProduktcodeHGX

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) 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 K252342. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)?

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) 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 K252342.

When did Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) receive FDA 510(k) clearance?

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252342.

Who is the listed applicant for Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)?

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 Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)?

The FDA product code for Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) is HGX.

Zugehörige klinische Studien

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Weitere Einträge mit Guangdong Youmeng Electrical Technology Co., Ltd. als Antragsteller

K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))K252754Wearable Electric Breast Pump (YM-8803)K232466Electric Breast Pump, model: YM-8166

Verwandte Geräte (Code: HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Offizielle Quelle

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