The following data is part of a premarket notification filed by Ekos Corp. with the FDA for Neurowave Micro-infusion System.
| Device ID | K062508 |
| 510k Number | K062508 |
| Device Name: | NEUROWAVE MICRO-INFUSION SYSTEM |
| Classification | Ultrasound, Infusion, System |
| Applicant | EKOS CORP. 11911 NORTH CREEK PKWY. SOUTH Bothell, WA 98011 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten EKOS CORP. 11911 NORTH CREEK PKWY. SOUTH Bothell, WA 98011 |
| Product Code | NUI |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-12-05 |
| Summary: | summary |