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FDA 510(k)

Imbio PHA (4.0.0)

K-Number: K241847 · 2024-08-30

ApplicantImbio, Inc.
Decision Date2024-08-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Imbio PHA (4.0.0) is a medical device manufactured by Imbio, Inc.. It received FDA 510(k) clearance on 2024-08-30 under approval number K241847. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imbio PHA (4.0.0)?

Imbio PHA (4.0.0) is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Imbio, Inc.. The 510(k) number is K241847.

When was Imbio PHA (4.0.0) approved by the FDA?

Imbio PHA (4.0.0) received FDA 510(k) clearance on 2024-08-30, under approval number K241847.

What company makes Imbio PHA (4.0.0)?

Imbio PHA (4.0.0) is manufactured by Imbio, Inc..

What is the FDA product code for Imbio PHA (4.0.0)?

The FDA product code for Imbio PHA (4.0.0) is QIH.

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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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