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 Monitor, Extracellular Fluid, Lymphedema, Extremity
510(k) Number K143310
Device Name MoisturemeterD
Applicant
DELFIN TECHNOLOGIES LTD.
MICROKATU 1
KUDPIO,  FI 70210
Applicant Contact Theodore Sullivan
Correspondent
BUCHANAN INGERSOL AND ROONEY
1700 K STREET, N.W.
SUITE 300
WASHINGTON,  DC  20006 -3807
Correspondent Contact Theodore Sullivan
Regulation Number870.2770
Classification Product Code
OBH  
Date Received11/18/2014
Decision Date 11/19/2015
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
-
-