The following data is part of a premarket notification filed by Bsd Medical Corp. with the FDA for Microthermx Microwave Ablation System, Models Mtx-180 Or Mtx.
| Device ID | K100786 |
| 510k Number | K100786 |
| Device Name: | MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | BSD MEDICAL CORP. 148 S. 1200 E. Salt Lake City, UT 84102 |
| Contact | Dixie Toolson Sells |
| Correspondent | Dixie Toolson Sells BSD MEDICAL CORP. 148 S. 1200 E. Salt Lake City, UT 84102 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-08-13 |
| Summary: | summary |