The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Dyevert Plus Contrast Modulation/monitoring System, Contrast Monitoring System.
| Device ID | K163054 |
| 510k Number | K163054 |
| Device Name: | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | OSPREY MEDICAL, INC. 5600 ROWLAND ROAD SUITE 250 Minnetonka, MN 55343 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess OSPREY MEDICAL, INC. 5600 ROWLAND ROAD SUITE 250 Minnetonka, MN 55343 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-03-08 |
| Summary: | summary |