VenAir, Sequential Compression System— 510(k) K213577

Name: FDA 510(k) clearance K213577
Creator: U.S. Food and Drug Administration
Published: 2022-06-28

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K213577 for VenAir, Sequential Compression System, Substantially Equivalent on 2022-06-28. Applicant: Apex Medical Corp.. Device class: 2.

Clearance details

Applicant: Apex Medical Corp.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2021-11-10
Decision date: 2022-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.