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 Other Than Applying Therapeutic Deep Heat
510(k) Number K882816
Device Name PULSAR EM
Applicant
Apex Medical, Inc.
990 Dillman Rd.
Martinsville,  IN  46151
Applicant Contact LARRY INMAN
Correspondent
Apex Medical, Inc.
990 Dillman Rd.
Martinsville,  IN  46151
Correspondent Contact LARRY INMAN
Regulation Number890.5290
Classification Product Code
ILX  
Date Received07/08/1988
Decision Date 04/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-