GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX

System, Imaging, Pulsed Doppler, Ultrasonic

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Vivid 7 Model Fc008xx, Ge Vivid 7 Model Fc009xx.

Pre-market Notification Details

• Device ID: K060542
• 510k Number: K060542
• Device Name: GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GENERAL ELECTRIC CO. 4855 WESTELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219
• Contact: Allen Schuh
• Correspondent: Monica Morrison; GENERAL ELECTRIC CO. P.O. BOX 7550 Madison, WI 53707
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-01
• Decision Date: 2006-03-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682115346	K060542	000
00840682113281	K060542	000
00840682113045	K060542	000
00840682105248	K060542	000