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 Calculator, Drug Dose
510(k) Number K160949
Device Name Go Dose System
Applicant
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Applicant Contact SUMITRA M GHATE
Correspondent
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Correspondent Contact SUMITRA M GHATE
Regulation Number868.1890
Classification Product Code
NDC  
Date Received04/05/2016
Decision Date 12/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-