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

Premarket Approval (PMA)

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


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
Classification Nameapplicator, hyperthermia, deep heating, ultrasound
Generic Nameultrasound hyperthermia system
ApplicantLABTHERMICS TECHNOLOGIES, INC.
PMA NumberP880062
Supplement NumberS002
Date Received12/16/1996
Decision Date02/13/1997
Product Code
LNB
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the computer system and revisions to the operator's manual for the sonotherm 1000.
-
-