The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthconnect Remote Viewing, Planning And Collaboration System.
| Device ID | K162655 |
| 510k Number | K162655 |
| Device Name: | StealthConnect Remote Viewing, Planning And Collaboration System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | Monica R. Montanez |
| Correspondent | Monica R. Montanez 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 | 2016-09-23 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169705432 | K162655 | 000 |