FDA 510(k)

Vision Monitor - MonpackONE

K-Number: K211643 · 2021-07-26

Decision Date2021-07-26

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Vision Monitor - MonpackONE is the device name listed in this FDA 510(k) record. The listed applicant is Metrovision. It received FDA 510(k) clearance on 2021-07-26 under 510(k) number K211643. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vision Monitor - MonpackONE?

Vision Monitor - MonpackONE is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Metrovision. The 510(k) number is K211643.

When did Vision Monitor - MonpackONE receive FDA 510(k) clearance?

Vision Monitor - MonpackONE received FDA 510(k) clearance on 2021-07-26, under 510(k) number K211643.

Who is the listed applicant for Vision Monitor - MonpackONE?

The FDA 510(k) record lists Metrovision as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vision Monitor - MonpackONE?

The FDA product code for Vision Monitor - MonpackONE is GWE.

Other records listing Metrovision as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212936Vision Monitor- MonCvONE

Related Devices (Code: GWE)

K221471E3 and ProfileDiagnosys, LLC K212936Vision Monitor- MonCvONEMetrovision K211974LED PHOTIC SystemMicromed S.P.A.K200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.