FDA 510(k)

Wearable breast pump

Numéro K : K221598 · 2022-12-09

Date de décision2022-12-09

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Wearable breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Mayborn (Uk) Limited. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K221598. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Wearable breast pump?

Wearable breast pump is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Mayborn (Uk) Limited. The 510(k) number is K221598.

When did Wearable breast pump receive FDA 510(k) clearance?

Wearable breast pump received FDA 510(k) clearance on 2022-12-09, under 510(k) number K221598.

Who is the listed applicant for Wearable breast pump?

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

What is the FDA product code for Wearable breast pump?

The FDA product code for Wearable breast pump is HGX.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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