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FDA 510(k)

One Mum Pumpset

K-Number: K172067 · 2017-11-29

ApplicantArdo Medical AG
Decision Date2017-11-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

One Mum Pumpset is the device name listed in this FDA 510(k) record. The listed applicant is Ardo Medical AG. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172067. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One Mum Pumpset?

One Mum Pumpset is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Ardo Medical AG. The 510(k) number is K172067.

When did One Mum Pumpset receive FDA 510(k) clearance?

One Mum Pumpset received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172067.

Who is the listed applicant for One Mum Pumpset?

The FDA 510(k) record lists Ardo Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Mum Pumpset?

The FDA product code for One Mum Pumpset is HGX.

Other records listing Ardo Medical AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230590ARDO BellisK212773ARDO Alyssa

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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