• 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 monitor, extracellular fluid, lymphedema, extremity
510(k) Number K172122
Device Name SOZO
ImpediMed Limited
Unit 1
50 Parker Court
pinkenba,  AU 4008
Applicant Contact catherine kingsford
ImpediMed Inc.
5900 Pasteur Court
Unit 125
carlsbad,  CA  92008
Correspondent Contact reuben lawson
Regulation Number870.2770
Classification Product Code
Date Received07/13/2017
Decision Date 08/11/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No