The following data is part of a premarket notification filed by Northwind Technologies, Corp. with the FDA for Mobile I.v. Systems 10,20,60.
| Device ID | K080695 |
| 510k Number | K080695 |
| Device Name: | MOBILE I.V. SYSTEMS 10,20,60 |
| Classification | Set, Administration, Intravascular |
| Applicant | NORTHWIND TECHNOLOGIES, CORP. 20171 BOWENS RD. Manchester, MI 48158 |
| Contact | Dawn I Moore |
| Correspondent | Dawn I Moore NORTHWIND TECHNOLOGIES, CORP. 20171 BOWENS RD. Manchester, MI 48158 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-07-01 |
| Summary: | summary |