The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Contrast Modulation System.
| Device ID | K140425 |
| 510k Number | K140425 |
| Device Name: | CONTRAST MODULATION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | OSPREY MEDICAL, INC. 5600 ROWLAND ROAD SUITE 250 Minnetonka, MN 55343 |
| Contact | Jill Munsinger |
| Correspondent | Jill Munsinger 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 | 2014-02-19 |
| Decision Date | 2014-06-11 |
| Summary: | summary |