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FDA 510(k)

Veinoflow SCD(型號:LBTK-M-I 5006)

K 號:K213313 · 2022-02-09

決定日期2022-02-09
產品代碼JOW
諮詢委員會履歷
決定相當於

器材摘要

Veinoflow SCD (Model: LBTK-M-I 5006) is the device name listed in this FDA 510(k) record. The listed applicant is Dalian Labtek Science & Development Co., Ltd.. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K213313. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Veinoflow SCD (Model: LBTK-M-I 5006)?

Veinoflow SCD (Model: LBTK-M-I 5006) is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Dalian Labtek Science & Development Co., Ltd.. The 510(k) number is K213313.

When did Veinoflow SCD (Model: LBTK-M-I 5006) receive FDA 510(k) clearance?

Veinoflow SCD (Model: LBTK-M-I 5006) received FDA 510(k) clearance on 2022-02-09, under 510(k) number K213313.

Who is the listed applicant for Veinoflow SCD (Model: LBTK-M-I 5006)?

The FDA 510(k) record lists Dalian Labtek Science & Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Veinoflow SCD (Model: LBTK-M-I 5006)?

The FDA product code for Veinoflow SCD (Model: LBTK-M-I 5006) is JOW.

相關臨床試驗

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相關器械(代碼:JOW)

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。

官方來源

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