The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Padnet+.
| Device ID | K073146 |
| 510k Number | K073146 |
| Device Name: | PADNET+ |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | BIOMEDIX, INC. 4215 WHITE BEAR PKWY. SUITE 200 Vadnais Heights, MN 55110 |
| Contact | William Rogers |
| Correspondent | William Rogers BIOMEDIX, INC. 4215 WHITE BEAR PKWY. SUITE 200 Vadnais Heights, MN 55110 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2007-11-21 |
| Summary: | summary |