The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Vivid 3 Expert; Ge Vivid 3 Pro.
Device ID | K020789 |
510k Number | K020789 |
Device Name: | GE VIVID 3 EXPERT; GE VIVID 3 PRO |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-11 |
Decision Date | 2002-04-04 |
Summary: | summary |