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 analyzer, body composition
510(k) Number K130311
Device Name TRANSTEK BODY FAT ANALYZER
Applicant
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU,  CN 610041
Applicant Contact LEO WANG
Correspondent
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU,  CN 610041
Correspondent Contact LEO WANG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received02/08/2013
Decision Date 05/30/2013
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
-
-