ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)— 510(k) K241132

Name: FDA 510(k) clearance K241132
Creator: U.S. Food and Drug Administration
Published: 2024-12-18

Substantially Equivalent

Artsmedia Denmark Aps

FDA 510(k) clearance K241132 for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100), Substantially Equivalent on 2024-12-18. Applicant: Artsmedia Denmark Aps. Device class: 2.

Clearance details

Applicant: Artsmedia Denmark Aps
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-04-24
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virum, DK

Download summary PDF View on FDA.gov ↗

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