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FDA 510(k)

imani i2Plus Breast Pump

K-Number: K222573 · 2023-03-03

ApplicantImani Co.
Decision Date2023-03-03
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

imani i2Plus Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Imani Co.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K222573. 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 imani i2Plus Breast Pump?

imani i2Plus Breast Pump is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Imani Co.. The 510(k) number is K222573.

When did imani i2Plus Breast Pump receive FDA 510(k) clearance?

imani i2Plus Breast Pump received FDA 510(k) clearance on 2023-03-03, under 510(k) number K222573.

Who is the listed applicant for imani i2Plus Breast Pump?

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

What is the FDA product code for imani i2Plus Breast Pump?

The FDA product code for imani i2Plus Breast Pump is HGX.

Other records listing Imani Co. 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.

K202037imani i2K202045imani i1

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

View on FDA Database →

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

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