The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson I/e.
| Device ID | K131937 |
| 510k Number | K131937 |
| Device Name: | VOLUSON I/E |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682119672 | K131937 | 000 |
| 00840682118040 | K131937 | 000 |
| 00840682114462 | K131937 | 000 |
| 00840682107754 | K131937 | 000 |
| 00840682107617 | K131937 | 000 |
| 00840682107600 | K131937 | 000 |
| 00840682104920 | K131937 | 000 |