Vision Monitor - MonpackONE— 510(k) K211643

Substantially Equivalent

Metrovision

FDA 510(k) clearance K211643 for Vision Monitor - MonpackONE, Substantially Equivalent on 2021-07-26. Applicant: Metrovision. Device class: 2.

Clearance details

Applicant: Metrovision
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2021-05-27
Decision date: 2021-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perenchies, FR

Download summary PDF View on FDA.gov ↗

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