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FDA 510(k)

EZ-Cover

K-Number: K191491 · 2020-06-05

ApplicantMedxpress.Pro
Decision Date2020-06-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EZ-Cover is a medical device manufactured by Medxpress.Pro. It received FDA 510(k) clearance on 2020-06-05 under approval number K191491. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-Cover?

EZ-Cover is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by Medxpress.Pro. The 510(k) number is K191491.

When was EZ-Cover approved by the FDA?

EZ-Cover received FDA 510(k) clearance on 2020-06-05, under approval number K191491.

What company makes EZ-Cover?

EZ-Cover is manufactured by Medxpress.Pro.

What is the FDA product code for EZ-Cover?

The FDA product code for EZ-Cover is ITX.

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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.

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