The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Navigator Applications Suite.
| Device ID | K083098 |
| 510k Number | K083098 |
| Device Name: | NAVIGATOR APPLICATIONS SUITE |
| Classification | Gas-machine, Anesthesia |
| Applicant | GE HEALTHCARE FINLAND OY 3030 OHMEDA DRIVE PO BOX 7550 Madison, WI 53707 -7550 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz GE HEALTHCARE FINLAND OY 3030 OHMEDA DRIVE PO BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-17 |
| Decision Date | 2009-04-01 |
| Summary: | summary |