The following data is part of a premarket notification filed by Lifelines Ltd. with the FDA for Trackit T4 Eeg Amplifier.
| Device ID | K172271 |
| 510k Number | K172271 |
| Device Name: | Trackit T4 EEG Amplifier |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Lifelines Ltd. 7 Clarendon Court Over Wallop, GB So20 8hu |
| Contact | Michael Hulin |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060275450653 | K172271 | 000 |
| 05060275450646 | K172271 | 000 |