The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Versalab.
| Device ID | K010521 |
| 510k Number | K010521 |
| Device Name: | NICOLET VERSALAB |
| Classification | Monitor, Ultrasonic, Nonfetal |
| 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 | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830029896 | K010521 | 000 |
| 00382830029889 | K010521 | 000 |
| 00382830029872 | K010521 | 000 |
| 00382830029865 | K010521 | 000 |
| 00382830029858 | K010521 | 000 |
| 00382830028165 | K010521 | 000 |
| 00382830028158 | K010521 | 000 |
| 00382830027915 | K010521 | 000 |
| 00382830027908 | K010521 | 000 |