FDA 510(k)

MYAH

K-Number: K211868 · 2022-03-01

Decision Date2022-03-01

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MYAH is the device name listed in this FDA 510(k) record. The listed applicant is Visia Imaging S.R.L.. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K211868. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYAH?

MYAH is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Visia Imaging S.R.L.. The 510(k) number is K211868.

When did MYAH receive FDA 510(k) clearance?

MYAH received FDA 510(k) clearance on 2022-03-01, under 510(k) number K211868.

Who is the listed applicant for MYAH?

The FDA 510(k) record lists Visia Imaging S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYAH?

The FDA product code for MYAH is MXK.

Other records listing Visia Imaging S.R.L. 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.

K222933MYAH K160327ALADDIN HW3.0

Related Devices (Code: MXK)

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation K223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH K201724Pentacam AXL WaveOculus Optikgerate GmbH

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.