FDA 510(k)

imani i2

K-Number: K202037 · 2021-03-01

Decision Date2021-03-01

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

imani i2 is a medical device manufactured by Imani Co.. It received FDA 510(k) clearance on 2021-03-01 under approval 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. It is manufactured by Imani Co.. The 510(k) number is K202037.

When was imani i2 approved by the FDA?

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

What company makes imani i2?

imani i2 is manufactured by Imani Co..

What is the FDA product code for imani i2?

The FDA product code for imani i2 is HGX.

Other Devices by Imani Co.

K202045imani i1 K222573imani i2Plus Breast Pump

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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.