EZ-Cover

Transducer, Ultrasonic, Diagnostic

MedXPress.Pro

The following data is part of a premarket notification filed by Medxpress.pro with the FDA for Ez-cover.

Pre-market Notification Details

• Device ID: K191491
• 510k Number: K191491
• Device Name: EZ-Cover
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: MedXPress.Pro Slachthuislaan 1, Bus 102 Leuven, BE 3000
• Contact: Katherine Hughey
• Correspondent: Jeff Kasoff; Lean To Quality, LLC 107 Avenue A Willis, TX 77378
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-05
• Decision Date: 2020-06-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05407006211181	K191491	000
05407006211631	K191491	000
05407006211600	K191491	000
05407006211570	K191491	000
05407006211549	K191491	000
05407006211518	K191491	000
05407006211488	K191491	000
05407006211457	K191491	000
05407006211426	K191491	000
05407006211396	K191491	000
05407006211365	K191491	000
05407006211334	K191491	000
05407006211303	K191491	000
05407006211273	K191491	000
05407006211242	K191491	000
05407006211662	K191491	000
05407006210733	K191491	000
05407006211150	K191491	000
05407006211129	K191491	000
05407006211099	K191491	000
05407006211068	K191491	000
05407006211037	K191491	000
05407006211006	K191491	000
05407006210979	K191491	000
05407006210948	K191491	000
05407006210917	K191491	000
05407006210887	K191491	000
05407006210856	K191491	000
05407006210825	K191491	000
05407006210795	K191491	000
05407006210764	K191491	000
05407006211211	K191491	000