• 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 K043414
Device Name HL 188 & HL 189 BODY FAT METER
Applicant
HEALTH & LIFE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
HEALTH & LIFE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.2770
Classification Product Code
MNW  
Date Received12/13/2004
Decision Date 02/09/2005
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
-
-