Applied Medical Anoscope— 510(k) K200021

Name: FDA 510(k) clearance K200021
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K200021 for Applied Medical Anoscope, Substantially Equivalent on 2021-01-06. Applicant: Applied Medical Resources. Device class: 2.

Clearance details

Applicant: Applied Medical Resources
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-01-06
Decision date: 2021-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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