Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • 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
Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K872393
Device Name SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact HENLEY, PHD
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact HENLEY, PHD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received06/12/1987
Decision Date 07/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-