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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 the device name listed in this FDA 510(k) record. The listed applicant is Bunkerhill, Inc.. It received FDA 510(k) clearance on 2023-04-25 under 510(k) 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. The listed applicant is Bunkerhill, Inc.. The 510(k) number is K230223.

When did iCAC Device receive FDA 510(k) clearance?

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

Who is the listed applicant for iCAC Device?

The FDA 510(k) record lists Bunkerhill, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCAC Device?

The FDA product code for iCAC Device is JAK.

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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.

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