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FDA 510(k)

SeeFactorCT3

K-Number: K190856 · 2019-09-20

ApplicantEpica International, Inc.
Decision Date2019-09-20
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SeeFactorCT3 is a medical device manufactured by Epica International, Inc.. It received FDA 510(k) clearance on 2019-09-20 under approval number K190856. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeeFactorCT3?

SeeFactorCT3 is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Epica International, Inc.. The 510(k) number is K190856.

When was SeeFactorCT3 approved by the FDA?

SeeFactorCT3 received FDA 510(k) clearance on 2019-09-20, under approval number K190856.

What company makes SeeFactorCT3?

SeeFactorCT3 is manufactured by Epica International, Inc..

What is the FDA product code for SeeFactorCT3?

The FDA product code for SeeFactorCT3 is OAS.

Other Devices by Epica International, Inc.

K233230See Factor CT3™

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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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