The following data is part of a premarket notification filed by Mibetec, Gmbh with the FDA for Bite Away Neo.
| Device ID | K220514 |
| 510k Number | K220514 |
| Device Name: | Bite Away Neo |
| Classification | Pad, Heating, Powered |
| Applicant | MibeTec, GmbH Munchener Strasse 15 Brehna, DE D-06796 |
| Contact | Oliver Grunert |
| Correspondent | Kenneth Kleinhenz QSR Consulting 10807 Dakota Ranch Rd. Santee, CA 92071 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-06-23 |