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 the device name listed in this FDA 510(k) record. The listed applicant is Epica International, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) 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. The listed applicant is Epica International, Inc.. The 510(k) number is K233230.

When did See Factor CT3™ receive FDA 510(k) clearance?

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

Who is the listed applicant for See Factor CT3™?

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

What is the FDA product code for See Factor CT3™?

The FDA product code for See Factor CT3™ is OWB.

Other records listing Epica International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.