FDA 510(k)

Veinoflow SCD (Model: LBTK-M-I 5006)

Número K: K213313 · 2022-02-09

RequerenteDalian Labtek Science & Development Co., Ltd.

Data da decisão2022-02-09

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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