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 Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K864766
Device Name SOUNDTEK MODEL UT-4700
Applicant
Soundtek, Inc.
2520 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact ERWIN H STARK
Correspondent
Soundtek, Inc.
2520 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact ERWIN H STARK
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received12/05/1986
Decision Date 03/12/1987
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
-
-