The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Fusion Compact Navigation System.
| Device ID | K153247 |
| 510k Number | K153247 |
| Device Name: | Fusion Compact Navigation System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha 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 | 2015-11-09 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169791862 | K153247 | 000 |
| 00643169693616 | K153247 | 000 |
| 00643169691964 | K153247 | 000 |
| 00643169672956 | K153247 | 000 |
| 00643169647121 | K153247 | 000 |
| 00763000099787 | K153247 | 000 |
| 00763000573263 | K153247 | 000 |