The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Versalab Apm.
| Device ID | K013281 |
| 510k Number | K013281 |
| Device Name: | VERSALAB APM |
| Classification | System, Monitoring, Perinatal |
| 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 | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-02 |
| Decision Date | 2002-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028554 | K013281 | 000 |
| 00382830028547 | K013281 | 000 |
| 00382830028530 | K013281 | 000 |
| 00382830028141 | K013281 | 000 |
| 00382830028134 | K013281 | 000 |
| 00382830028127 | K013281 | 000 |
| 00382830027892 | K013281 | 000 |
| 00382830027885 | K013281 | 000 |