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FDA 510(k)

iCAC Device

K-Number: K230223 · 2023-04-25

ApplicantBunkerhill, Inc.
Decision Date2023-04-25
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iCAC Device is a medical device manufactured by Bunkerhill, Inc.. It received FDA 510(k) clearance on 2023-04-25 under approval number K230223. 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 iCAC Device?

iCAC Device is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Bunkerhill, Inc.. The 510(k) number is K230223.

When was iCAC Device approved by the FDA?

iCAC Device received FDA 510(k) clearance on 2023-04-25, under approval number K230223.

What company makes iCAC Device?

iCAC Device is manufactured by Bunkerhill, Inc..

What is the FDA product code for iCAC Device?

The FDA product code for iCAC Device is JAK.

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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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