The following data is part of a premarket notification filed by Bsd Medical Systems Corp. with the FDA for Microthermx-100 Microwave Ablation System And Accessories.
| Device ID | K081042 |
| 510k Number | K081042 |
| Device Name: | MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | BSD MEDICAL SYSTEMS CORP. 148 S. 1200 E. Salt Lake City, UT 84102 -1643 |
| Contact | Phil Triolo |
| Correspondent | Phil Triolo BSD MEDICAL SYSTEMS CORP. 148 S. 1200 E. Salt Lake City, UT 84102 -1643 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-11 |
| Decision Date | 2008-09-03 |
| Summary: | summary |