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 Stimulator, Muscle, Powered
510(k) Number K973223
Device Name STELLAR MODEL HS-04
Applicant
Stellar Medical Corp.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
Stellar Medical Corp.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
IRT   LIH  
Date Received08/27/1997
Decision Date 02/18/1998
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
-
-