Vision Monitor - MonpackONE
K-Number: K211643 · 2021-07-26
ApplicantMetrovision
Decision Date2021-07-26
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Vision Monitor - MonpackONE is a medical device manufactured by Metrovision. It received FDA 510(k) clearance on 2021-07-26 under approval 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. It is manufactured by Metrovision. The 510(k) number is K211643.
When was Vision Monitor - MonpackONE approved by the FDA?
Vision Monitor - MonpackONE received FDA 510(k) clearance on 2021-07-26, under approval number K211643.
What company makes Vision Monitor - MonpackONE?
Vision Monitor - MonpackONE is manufactured by Metrovision.
What is the FDA product code for Vision Monitor - MonpackONE?
The FDA product code for Vision Monitor - MonpackONE is GWE.
Related Clinical Trials
Other Devices by Metrovision
Related Devices (Code: GWE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.