Graffiti

Computer, Diagnostic, Programmable

GE Medical Systems Information Technologies, Inc.

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Graffiti.

Pre-market Notification Details

• Device ID: K202189
• 510k Number: K202189
• Device Name: Graffiti
• Classification: Computer, Diagnostic, Programmable
• Applicant: GE Medical Systems Information Technologies, Inc. 9900 W Innovation Dr. Wauwatosa, WI 53226
• Contact: Camille Vidal
• Correspondent: Camille Vidal; GE Medical Systems Information Technologies, Inc. 9900 W Innovation Dr. Wauwatosa, WI 53226
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-04
• Decision Date: 2020-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682152754	K202189	000