FDA 510(k)

See Factor CT3

K-Number: K233230 · 2024-06-21

Decision Date2024-06-21

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

See Factor CT3 is a medical device manufactured by Epica International, Inc.. It received FDA 510(k) clearance on 2024-06-21 under approval number K233230. 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 See Factor CT3?

See Factor CT3 is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Epica International, Inc.. The 510(k) number is K233230.

When was See Factor CT3 approved by the FDA?

See Factor CT3 received FDA 510(k) clearance on 2024-06-21, under approval number K233230.

What company makes See Factor CT3?

See Factor CT3 is manufactured by Epica International, Inc..

What is the FDA product code for See Factor CT3?

The FDA product code for See Factor CT3 is OWB.

Other Devices by Epica International, Inc.

K190856SeeFactorCT3

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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.