The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstationtm S8 Ent Software.
| Device ID | K170018 |
| 510k Number | K170018 |
| Device Name: | StealthStationTM S8 ENT Software |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | K. Elizabeth Waite |
| Correspondent | K. Elizabeth Waite Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169931343 | K170018 | 000 |
| 00763000075095 | K170018 | 000 |
| 00763000075088 | K170018 | 000 |
| 00763000075071 | K170018 | 000 |
| 00763000075064 | K170018 | 000 |
| 00763000075019 | K170018 | 000 |
| 00763000064730 | K170018 | 000 |
| 00763000063177 | K170018 | 000 |
| 00763000238810 | K170018 | 000 |
| 00763000238742 | K170018 | 000 |
| 00643169843929 | K170018 | 000 |
| 00763000075101 | K170018 | 000 |
| 00763000075118 | K170018 | 000 |
| 00763000075217 | K170018 | 000 |
| 00643169858428 | K170018 | 000 |
| 00763000125295 | K170018 | 000 |
| 00763000125202 | K170018 | 000 |
| 00763000125066 | K170018 | 000 |
| 00763000116996 | K170018 | 000 |
| 00763000075668 | K170018 | 000 |
| 00763000075651 | K170018 | 000 |
| 00763000075644 | K170018 | 000 |
| 00763000075637 | K170018 | 000 |
| 00763000075309 | K170018 | 000 |
| 00763000234867 | K170018 | 000 |