The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Voluson I.
| Device ID | K053435 |
| 510k Number | K053435 |
| Device Name: | GE VOLUSON I |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53201 |
| Contact | Allen Smith |
| Correspondent | Allen Smith GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53201 |
| 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 | 2005-12-09 |
| Decision Date | 2005-12-16 |
| Summary: | summary |