The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Brightmatter Navigation System.
| Device ID | K142024 |
| 510k Number | K142024 |
| Device Name: | BRIGHTMATTER NAVIGATION SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Contact | Cameron Piron |
| Correspondent | Cameron Piron SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2015-04-02 |
| Summary: | summary |