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 accessories, pump, infusion
510(k) Number K120314
Device Name WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
Applicant
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE,  MD  21202
Applicant Contact LAUREN BRONICH-HALL
Correspondent
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE,  MD  21202
Correspondent Contact LAUREN BRONICH-HALL
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received02/01/2012
Decision Date 02/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-