The following data is part of a premarket notification filed by Lifelines Ltd. with the FDA for R-40 Eeg Amplifier.
| Device ID | K151600 |
| 510k Number | K151600 |
| Device Name: | R-40 EEG Amplifier |
| Classification | Amplifier, Physiological Signal |
| 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 | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060275450615 | K151600 | 000 |
| 05060275450448 | K151600 | 000 |
| 05060275450431 | K151600 | 000 |
| 05060275450424 | K151600 | 000 |
| 05060275450417 | K151600 | 000 |
| 05060275450400 | K151600 | 000 |
| 05060275450394 | K151600 | 000 |
| 05060275450387 | K151600 | 000 |
| 05060275450783 | K151600 | 000 |
| 05060275450776 | K151600 | 000 |
| 05060275450769 | K151600 | 000 |
| 05060275450752 | K151600 | 000 |
| 05060275450745 | K151600 | 000 |
| 05060275450738 | K151600 | 000 |
| 05060275450721 | K151600 | 000 |
| 05060275450455 | K151600 | 000 |
| 05060275450462 | K151600 | 000 |
| 05060275450608 | K151600 | 000 |
| 05060275450592 | K151600 | 000 |
| 05060275450585 | K151600 | 000 |
| 05060275450578 | K151600 | 000 |
| 05060275450561 | K151600 | 000 |
| 05060275450554 | K151600 | 000 |
| 05060275450547 | K151600 | 000 |
| 05060275450530 | K151600 | 000 |
| 05060275450523 | K151600 | 000 |
| 05060275450516 | K151600 | 000 |
| 05060275450509 | K151600 | 000 |
| 05060275450493 | K151600 | 000 |
| 05060275450486 | K151600 | 000 |
| 05060275450479 | K151600 | 000 |
| 05060275450714 | K151600 | 000 |