• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBSD-2000 HYPERTHERMIA SYSTEM
Classification Namerf/microwave hyperthermia system, cancer treatment
Generic Namerf/microwave hyperthermia system, cancer treatment
Applicant
PYREXAR MEDICAL INC
2188 west 2200 south
suite a
salt lake city, UT 84119-1326
HDE NumberH090002
Date Received05/26/2009
Decision Date11/18/2011
Product Code
PAS
Docket Number 11M-0848
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
-
-