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FDA 510(k)

imani i2

K-Number: K202037 · 2021-03-01

ApplicantImani Co.
Decision Date2021-03-01
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

imani i2 is the device name listed in this FDA 510(k) record. The listed applicant is Imani Co.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K202037. 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 i2?

imani i2 is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Imani Co.. The 510(k) number is K202037.

When did imani i2 receive FDA 510(k) clearance?

imani i2 received FDA 510(k) clearance on 2021-03-01, under 510(k) number K202037.

Who is the listed applicant for imani i2?

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 i2?

The FDA product code for imani i2 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.

K222573imani i2Plus Breast PumpK202045imani 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

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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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