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FDA 510(k)

See Factor CT3™

K号: K233230 · 2024-06-21

决定日期2024-06-21
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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列明Epica International, Inc.为申报人的其他记录

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相关器械(代码:OWB)

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官方来源

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