FDA 510(k)

EZ-Cover

K-Number: K191491 · 2020-06-05

Decision Date2020-06-05

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EZ-Cover is the device name listed in this FDA 510(k) record. The listed applicant is Medxpress.Pro. It received FDA 510(k) clearance on 2020-06-05 under 510(k) 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. The listed applicant is Medxpress.Pro. The 510(k) number is K191491.

When did EZ-Cover receive FDA 510(k) clearance?

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

Who is the listed applicant for EZ-Cover?

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

What is the FDA product code for EZ-Cover?

The FDA product code for EZ-Cover is ITX.

Related Devices (Code: ITX)

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.

K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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.