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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 the device name listed in this FDA 510(k) record. The listed applicant is Epica International, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) 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. The listed applicant is Epica International, Inc.. The 510(k) number is K190856.

When did SeeFactorCT3 receive FDA 510(k) clearance?

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

Who is the listed applicant for SeeFactorCT3?

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 SeeFactorCT3?

The FDA product code for SeeFactorCT3 is OAS.

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.

K233230See Factor CT3™

Related Devices (Code: OAS)

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.

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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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