FDA 510(k)

VitroPRO

K 號：K231783 · 2023-11-14

決定日期2023-11-14

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

VitroPRO is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K231783. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitroPRO?

VitroPRO is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K231783.

When did VitroPRO receive FDA 510(k) clearance?

VitroPRO received FDA 510(k) clearance on 2023-11-14, under 510(k) number K231783.

Who is the listed applicant for VitroPRO?

FDA 510(k) 記錄將 CIVCO Medical Instruments Co., Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for VitroPRO?

The FDA product code for VitroPRO is ITX.

其他以 CIVCO Medical Instruments Co., Inc. 為申請人之記錄

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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相關器械（代碼：ITX）

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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