The following data is part of a premarket notification filed by Amdev, Inc. with the FDA for Lytening 2.
| Device ID | K863521 |
| 510k Number | K863521 |
| Device Name: | LYTENING 2 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Contact | Schwartz, Md |
| Correspondent | Schwartz, Md AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-10 |
| Decision Date | 1986-11-05 |