The following data is part of a premarket notification filed by Artronics with the FDA for Neuroreader.
| Device ID | K950986 |
| 510k Number | K950986 |
| Device Name: | NEUROREADER |
| Classification | Device, Temperature Measurement, Direct Contact, Powered |
| Applicant | ARTRONICS 464 SWEETBRIAR WAY Easley, SC 29640 |
| Contact | Robert A Teague |
| Correspondent | Robert A Teague ARTRONICS 464 SWEETBRIAR WAY Easley, SC 29640 |
| Product Code | HCS |
| CFR Regulation Number | 882.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-11-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEUROREADER 88711549 not registered Live/Pending |
Brainreader ApS 2019-12-02 |