DIGDOP ULTRASOUND SYSTEM

Transducer, Ultrasonic, Diagnostic

THE NEWMAN GROUP, LLC

The following data is part of a premarket notification filed by The Newman Group, Llc with the FDA for Digdop Ultrasound System.

Pre-market Notification Details

• Device ID: K090465
• 510k Number: K090465
• Device Name: DIGDOP ULTRASOUND SYSTEM
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: THE NEWMAN GROUP, LLC 42 SHERWOOD TERRACE SUITE 2 Lake Bluff, IL 60044
• Contact: Spencer Newman
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-02-23
• Decision Date: 2009-04-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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