The following data is part of a premarket notification filed by Velocimed Inc. with the FDA for Proxis System, Model Eps 101.
| Device ID | K042117 |
| 510k Number | K042117 |
| Device Name: | PROXIS SYSTEM, MODEL EPS 101 |
| Classification | Catheter, Percutaneous |
| Applicant | VELOCIMED INC. 6550 WEDGWOOD RD. NORTH SUITE 150 Minneapolis, MN 55311 |
| Contact | John Carline |
| Correspondent | John Carline VELOCIMED INC. 6550 WEDGWOOD RD. NORTH SUITE 150 Minneapolis, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-05 |
| Decision Date | 2005-01-07 |
| Summary: | summary |