The following data is part of a premarket notification filed by Collaborative Care Diagnostics Llc, D.b.a. Biomedix with the FDA for Padnet Xpress.
| Device ID | K220527 |
| 510k Number | K220527 |
| Device Name: | PADnet Xpress |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | Collaborative Care Diagnostics LLC, D.b.a. Biomedix 860 Blue Gentian Rd Suite 180 Eagan, MN 55121 |
| Contact | James Hartnett |
| Correspondent | James Hartnett Collaborative Care Diagnostics LLC, D.b.a. Biomedix 860 Blue Gentian Rd Suite 180 Eagan, MN 55121 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-10-20 |