Disposable Endoscope Valve Sets— 510(k) K220884

Name: FDA 510(k) clearance K220884
Creator: U.S. Food and Drug Administration
Published: 2023-01-17

Substantially Equivalent

Sml Med-Tech Solutions Limited

FDA 510(k) clearance K220884 for Disposable Endoscope Valve Sets, Substantially Equivalent on 2023-01-17. Applicant: Sml Med-Tech Solutions Limited. Device class: 2.

Clearance details

Applicant: Sml Med-Tech Solutions Limited
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-28
Decision date: 2023-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fo Tan, N.T., CN

Download summary PDF View on FDA.gov ↗

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