The following data is part of a premarket notification filed by Medtronic Navigation Inc. with the FDA for Stealthstation Cranial Software V1.3.0.
| Device ID | K201175 |
| 510k Number | K201175 |
| Device Name: | StealthStation Cranial Software V1.3.0 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Amelia Striegel |
| Correspondent | Amelia Striegel Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000378424 | K201175 | 000 |
| 00763000374167 | K201175 | 000 |
| 00763000373986 | K201175 | 000 |
| 00763000373665 | K201175 | 000 |
| 00763000373580 | K201175 | 000 |
| 00763000373429 | K201175 | 000 |
| 00763000395360 | K201175 | 000 |
| 00763000376055 | K201175 | 000 |