• 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 analyzer, body composition
510(k) Number K112149
Device Name WEIGHT AND BODY FAT SCALE SHINE BS0105
Applicant
SHINE OVERSEAS MARKETING LIMITED
77325 JOYCE WAY
ECHO,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
SHINE OVERSEAS MARKETING LIMITED
77325 JOYCE WAY
ECHO,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number870.2770
Classification Product Code
MNW  
Date Received07/26/2011
Decision Date 04/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-