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 |