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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 a medical device manufactured by Imani Co.. It received FDA 510(k) clearance on 2023-03-03 under approval 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. It is manufactured by Imani Co.. The 510(k) number is K222573.

When was imani i2Plus Breast Pump approved by the FDA?

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

What company makes imani i2Plus Breast Pump?

imani i2Plus Breast Pump is manufactured by Imani Co..

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

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

Other Devices by Imani Co.

Related Devices (Code: HGX)

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.