PRIME-XV FreezIS DMSO-Free MD— 510(k) K231804

Name: FDA 510(k) clearance K231804
Creator: U.S. Food and Drug Administration
Published: 2023-11-09

Substantially Equivalent

Fujifilm Irvine Scientific

FDA 510(k) clearance K231804 for PRIME-XV FreezIS DMSO-Free MD, Substantially Equivalent on 2023-11-09. Applicant: Fujifilm Irvine Scientific. Device class: 2.

Clearance details

Applicant: Fujifilm Irvine Scientific
Product code: Code NDS
Device class: Class 2
Regulation: 21 CFR 876.5885
Advisory panel: Gastroenterology, Urology
Date received: 2023-06-20
Decision date: 2023-11-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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