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FDA 510(k)

Elvie Pump

K-Number: K181863 · 2018-10-10

ApplicantChiaro Technology Limited
Decision Date2018-10-10
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Elvie Pump is the device name listed in this FDA 510(k) record. The listed applicant is Chiaro Technology Limited. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K181863. 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 Elvie Pump?

Elvie Pump is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Chiaro Technology Limited. The 510(k) number is K181863.

When did Elvie Pump receive FDA 510(k) clearance?

Elvie Pump received FDA 510(k) clearance on 2018-10-10, under 510(k) number K181863.

Who is the listed applicant for Elvie Pump?

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

What is the FDA product code for Elvie Pump?

The FDA product code for Elvie Pump is HGX.

Other records listing Chiaro Technology Limited 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.

K242125Elvie Stride 2K210936Elvie Stride

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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