The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Caredop Ii.
| Device ID | K982635 |
| 510k Number | K982635 |
| Device Name: | CAREDOP II |
| 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 | 1998-07-13 |
| Decision Date | 1998-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028233 | K982635 | 000 |
| 00382830028226 | K982635 | 000 |
| 00382830028219 | K982635 | 000 |
| 00382830028202 | K982635 | 000 |
| 00382830028196 | K982635 | 000 |
| 00382830028059 | K982635 | 000 |
| 00382830028042 | K982635 | 000 |
| 00382830028035 | K982635 | 000 |
| 00382830028028 | K982635 | 000 |