• 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 K150910
Device Name ACCU-CHEK Connect Diabetes Management App
Applicant
ROCHE DIABETES CARE INC.
9115 HAGUE ROAD
indianapolis,  IN  46250 -0457
Applicant Contact chunhong tao
Correspondent
ROCHE DIABETES CARE INC.
9115 HAGUE ROAD
indianapolis,  IN  46250 -0457
Correspondent Contact chunhong tao
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Codes
JQP   LFR   LZG  
Date Received04/03/2015
Decision Date 06/03/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-