The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Padnet 2.0.
| Device ID | K122281 |
| 510k Number | K122281 |
| Device Name: | PADNET 2.0 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | BIOMEDIX, INC. 178 East 9th Street St. Paul, MN 55101 |
| Contact | Greg Hocking |
| Correspondent | Greg Hocking BIOMEDIX, INC. 178 East 9th Street St. Paul, MN 55101 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862467000302 | K122281 | 000 |