The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Navigator Applications Suite.
| Device ID | K102389 |
| 510k Number | K102389 |
| Device Name: | NAVIGATOR APPLICATIONS SUITE |
| Classification | Gas-machine, Anesthesia |
| Applicant | GE HEALTHCARE FINLAND OY PO BOX 7550 Madison, WI 53707 -7550 |
| Contact | Monica Morrison |
| Correspondent | Monica Morrison GE HEALTHCARE FINLAND OY PO BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-23 |
| Decision Date | 2011-06-10 |
| Summary: | summary |