The following data is part of a premarket notification filed by Btl with the FDA for Btl-899.
| Device ID | K192224 |
| 510k Number | K192224 |
| Device Name: | BTL-899 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BTL 362 Elm Street Marlborough, MA 01752 |
| Contact | David Chmel |
| Correspondent | David Chmel BTL 362 Elm Street Marlborough, MA 01752 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-16 |
| Decision Date | 2019-12-05 |