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FDA 510(k)

imani i1

K-Number: K202045 · 2021-02-26

ApplicantImani Co.
Decision Date2021-02-26
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

imani i1 is a medical device manufactured by Imani Co.. It received FDA 510(k) clearance on 2021-02-26 under approval number K202045. 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 i1?

imani i1 is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Imani Co.. The 510(k) number is K202045.

When was imani i1 approved by the FDA?

imani i1 received FDA 510(k) clearance on 2021-02-26, under approval number K202045.

What company makes imani i1?

imani i1 is manufactured by Imani Co..

What is the FDA product code for imani i1?

The FDA product code for imani i1 is HGX.

Other Devices by Imani Co.

K202037imani i2 K222573imani i2Plus Breast Pump

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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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