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 Injection Data Capture Device
510(k) Number K212217
Device Name Tempo Smart Button
Applicant
Eli Lilly and Company
Lilly Corporate Center
Indianapolis,  IL  46285
Applicant Contact Kevin S. Bardonner
Correspondent
Eli Lilly and Company
Lilly Corporate Center
Indianapolis,  IN  46285
Correspondent Contact Marcia Arentz
Regulation Number880.5860
Classification Product Code
QOG  
Subsequent Product Code
OCN  
Date Received07/16/2021
Decision Date 09/16/2022
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
-
-