|
Device | BSD-500 HYPERTHERMIA SYSTEM |
Generic Name | System, rf/microwave hyperthermia, cancer treatment |
Applicant | PYREXAR MEDICAL INC 2188 WEST 2200 SOUTH SUITE A SALT LAKE CITY, UT 84119 |
PMA Number | P820088 |
Supplement Number | S016 |
Date Received | 04/21/2003 |
Decision Date | 10/08/2003 |
Product Code |
LOC |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO REPLACE THE COMPUTER AND MONITOR AND FOR THE MINOR UPGRADE FOR THERMOMETRY CALIBRATION METHOD. |