The following data is part of a premarket notification filed by Medtronic Navigation Inc with the FDA for Stealthstation Synergy Cranial S7 Software V.2.2.8, Stealthstation Cranial Software V3.1.1.
| Device ID | K190672 |
| 510k Number | K190672 |
| Device Name: | StealthStation Synergy Cranial S7 Software V.2.2.8, StealthStation Cranial Software V3.1.1 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtronic Navigation Inc 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Elizabeth Waite |
| Correspondent | Elizabeth Waite Medtronic Navigation Inc 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-07-31 |
| Summary: | summary |