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FDA 510(k)

F3

K-Number: K222998 · 2023-06-20

ApplicantAcrew Imaging, Inc.
Decision Date2023-06-20
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

F3 is a medical device manufactured by Acrew Imaging, Inc.. It received FDA 510(k) clearance on 2023-06-20 under approval number K222998. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3?

F3 is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Acrew Imaging, Inc.. The 510(k) number is K222998.

When was F3 approved by the FDA?

F3 received FDA 510(k) clearance on 2023-06-20, under approval number K222998.

What company makes F3?

F3 is manufactured by Acrew Imaging, Inc..

What is the FDA product code for F3?

The FDA product code for F3 is OWB.

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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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