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FDA 510(k)

CAC Software

K-Number: K230112 · 2023-06-13

ApplicantImbio, Inc.
Decision Date2023-06-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAC Software is a medical device manufactured by Imbio, Inc.. It received FDA 510(k) clearance on 2023-06-13 under approval number K230112. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAC Software?

CAC Software is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Imbio, Inc.. The 510(k) number is K230112.

When was CAC Software approved by the FDA?

CAC Software received FDA 510(k) clearance on 2023-06-13, under approval number K230112.

What company makes CAC Software?

CAC Software is manufactured by Imbio, Inc..

What is the FDA product code for CAC Software?

The FDA product code for CAC Software is JAK.

Other Devices by Imbio, Inc.

K242467IQ-UIP K241847Imbio PHA (4.0.0)

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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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