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 K052319
Device Name IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
Applicant
Impedimed Pty , Ltd.
Bldg. 4b/2404 Logan Rd.
Eight Mile Plains
Brisbane, Queensland,  AU 4113
Applicant Contact NEVILLE BERTWISTLE
Correspondent
Impedimed Pty , Ltd.
Bldg. 4b/2404 Logan Rd.
Eight Mile Plains
Brisbane, Queensland,  AU 4113
Correspondent Contact NEVILLE BERTWISTLE
Regulation Number870.2770
Classification Product Code
MNW  
Date Received08/25/2005
Decision Date 04/04/2006
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
Predetermined Change
Control Plan Authorized		 No
-
-