The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Eme Legend Tc22.
| Device ID | K993939 |
| 510k Number | K993939 |
| Device Name: | NICOLET EME LEGEND TC22 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Contact | David W Wagner |
| Correspondent | David W Wagner NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-19 |
| Decision Date | 2000-06-29 |