The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Avert Contrast Modulation System.
Device ID | K150485 |
510k Number | K150485 |
Device Name: | AVERT Contrast Modulation 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-24 |
Decision Date | 2015-03-26 |
Summary: | summary |