The following data is part of a premarket notification filed by Kinetix with the FDA for Improved Mouthpiece.
| Device ID | K840459 |
| 510k Number | K840459 |
| Device Name: | IMPROVED MOUTHPIECE |
| Classification | Mouthpiece, Breathing |
| Applicant | KINETIX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-02 |
| Decision Date | 1984-02-17 |