The following data is part of a premarket notification filed by Btg International, Inc. with the FDA for Ekos Ultrasound Evd Device, Evd Control Unit.
| Device ID | K172035 |
| 510k Number | K172035 |
| Device Name: | EKOS Ultrasound EVD Device, EVD Control Unit |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | BTG International, Inc. 11911 North Creek Pkwy S Bothell, WA 98011 |
| Contact | Brit Baird |
| Correspondent | Jocelyn Kersten BTG International, Inc. 11911 North Creek Pkwy S Bothell, WA 98011 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2018-03-24 |