The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Voluson E8 Ultrasound System.
| Device ID | K061682 |
| 510k Number | K061682 |
| Device Name: | GE VOLUSON E8 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-07-12 |
| Summary: | summary |