The following data is part of a premarket notification filed by Btl Industries Ltd with the FDA for Xp200.
| Device ID | K122966 |
| 510k Number | K122966 |
| Device Name: | XP200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BTL INDUSTRIES LTD 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins BTL INDUSTRIES LTD 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2013-04-08 |
| Summary: | summary |