The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Biomedix Padnet Lab.
| Device ID | K042616 |
| 510k Number | K042616 |
| Device Name: | BIOMEDIX PADNET LAB |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | BIOMEDIX, INC. 4205 WHITE BEAR PKWY. St. Paul, MN 55110 |
| Contact | William Rogers |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-23 |
| Decision Date | 2004-10-12 |
| Summary: | summary |