CONI

System, Image Processing, Radiological

GLOBALMED

The following data is part of a premarket notification filed by Globalmed with the FDA for Coni.

Pre-market Notification Details

• Device ID: K130624
• 510k Number: K130624
• Device Name: CONI
• Classification: System, Image Processing, Radiological
• Applicant: GLOBALMED 15020 N. 74TH ST. Scottsdale, AZ 85260
• Contact: Nicholas Campbell
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2013-03-08
• Decision Date: 2013-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B377GMR1602008X0	K130624	000
B377GMD306100XXX0	K130624	000