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 K162532
FOIA Releasable 510(k) K162532
Device Name WellDoc BlueStar, WellDoc BlueStar Rx
Applicant
WELLDOC, INC
10221 WINCOPIN CIRCLE SUITE 150
COLUMBIA,  MD  21044
Applicant Contact DANIELLE DORFMAN
Correspondent
WELLDOC, INC
10221 WINCOPIN CIRCLE SUITE 150
COLUMBIA,  MD  21044
Correspondent Contact DANIELLE DORFMAN
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
NDC  
Date Received09/09/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-