The following data is part of a premarket notification filed by Roche Diabetes Care Inc. with the FDA for Accu-chek Connect Diabetes Management App.
Device ID | K150910 |
510k Number | K150910 |
Device Name: | ACCU-CHEK Connect Diabetes Management App |
Classification | Calculator, Drug Dose |
Applicant | ROCHE DIABETES CARE INC. 9115 HAGUE ROAD Indianapolis, IN 46250 -0457 |
Contact | Chunhong Tao |
Correspondent | Chunhong Tao ROCHE DIABETES CARE INC. 9115 HAGUE ROAD Indianapolis, IN 46250 -0457 |
Product Code | NDC |
Subsequent Product Code | JQP |
Subsequent Product Code | LFR |
Subsequent Product Code | LZG |
CFR Regulation Number | 868.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-03 |
Decision Date | 2015-06-03 |
Summary: | summary |