The following data is part of a premarket notification filed by Bsd Medical Corp. with the FDA for Micro Thermx Microwave Ablation System And Accessories.
Device ID | K141785 |
510k Number | K141785 |
Device Name: | MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
Classification | System, Ablation, Microwave And Accessories |
Applicant | BSD MEDICAL CORP. 2188 WEST 2200 SOUTH Salt Lake City, UT 84119 |
Contact | Dixie Toolson Sells |
Correspondent | Dixie Toolson Sells BSD MEDICAL CORP. 2188 WEST 2200 SOUTH Salt Lake City, UT 84119 |
Product Code | NEY |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-02 |
Decision Date | 2015-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851551005156 | K141785 | 000 |
00810563020526 | K141785 | 000 |
00810563020601 | K141785 | 000 |
00810563020595 | K141785 | 000 |
00810563021042 | K141785 | 000 |
00810563021035 | K141785 | 000 |
00810563021028 | K141785 | 000 |
00810563021011 | K141785 | 000 |
00810563021004 | K141785 | 000 |
00810563020991 | K141785 | 000 |
00810563020533 | K141785 | 000 |
00810563020540 | K141785 | 000 |
00810563020557 | K141785 | 000 |
00851551005095 | K141785 | 000 |
00851551005088 | K141785 | 000 |
00851551005071 | K141785 | 000 |
00851551005064 | K141785 | 000 |
00851551005019 | K141785 | 000 |
00851551005002 | K141785 | 000 |
00810563020588 | K141785 | 000 |
00810563020571 | K141785 | 000 |
00810563020564 | K141785 | 000 |
00810563020984 | K141785 | 000 |