The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Pioneer Tc8080.
| Device ID | K020754 |
| 510k Number | K020754 |
| Device Name: | NICOLET PIONEER TC8080 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NICOLET BIOMEDICAL 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring NICOLET BIOMEDICAL 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2003-04-21 |