The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Vasoguard.
| Device ID | K002766 |
| 510k Number | K002766 |
| Device Name: | NICOLET VASOGUARD |
| Classification | Transducer, 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 | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2000-11-30 |