The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Voluson 730 Pro/expert Untrasound Bt04.
| Device ID | K041688 |
| 510k Number | K041688 |
| Device Name: | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GENERAL ELECTRIC CO. 4855 WESTELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GENERAL ELECTRIC CO. 4855 WESTELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
| 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 | 2004-06-22 |
| Decision Date | 2004-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118194 | K041688 | 000 |
| 00840682107709 | K041688 | 000 |
| 00840682107723 | K041688 | 000 |
| 00840682108324 | K041688 | 000 |
| 00840682108362 | K041688 | 000 |
| 00840682117203 | K041688 | 000 |
| 00840682118019 | K041688 | 000 |
| 00840682118026 | K041688 | 000 |
| 00840682118125 | K041688 | 000 |
| 00840682118163 | K041688 | 000 |
| 00840682106528 | K041688 | 000 |