FDA 510(k)

解決管

K 號：K201026 · 2021-08-10

決定日期2021-08-10

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

sOLVe Tube is the device name listed in this FDA 510(k) record. The listed applicant is Hytek Medical, Inc.. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K201026. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the sOLVe Tube?

sOLVe Tube is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Hytek Medical, Inc.. The 510(k) number is K201026.

When did sOLVe Tube receive FDA 510(k) clearance?

sOLVe Tube received FDA 510(k) clearance on 2021-08-10, under 510(k) number K201026.

Who is the listed applicant for sOLVe Tube?

The FDA 510(k) record lists Hytek Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for sOLVe Tube?

The FDA product code for sOLVe Tube is CBI.

相關器械（代碼：CBI）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：CBI）

官方來源