FDA 510(k)

請參考 Factor CT3™

K 號：K233230 · 2024-06-21

決定日期2024-06-21

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Epica International, Inc. 為申請人之記錄

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K190856SeeFactorCT3

相關器械（代碼：OWB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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