The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Vivid E9 Ultrasound.
| Device ID | K081921 |
| 510k Number | K081921 |
| Device Name: | GE VIVID E9 ULTRASOUND |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-08-06 |
| Summary: | summary |