Veinoflow SCD (Model: LBTK-M-I 5006)— 510(k) K213313

Name: FDA 510(k) clearance K213313
Creator: U.S. Food and Drug Administration
Published: 2022-02-09

Substantially Equivalent

Dalian Labtek Science & Development Co., Ltd.

FDA 510(k) clearance K213313 for Veinoflow SCD (Model: LBTK-M-I 5006), Substantially Equivalent on 2022-02-09. Applicant: Dalian Labtek Science & Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dalian Labtek Science & Development Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2021-10-04
Decision date: 2022-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dalian, CN

Download summary PDF View on FDA.gov ↗

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