The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Smartlog Diabetes Management Software.
Device ID | K133346 |
510k Number | K133346 |
Device Name: | SMARTLOG DIABETES MANAGEMENT SOFTWARE |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, Korea, KR 139-845 |
Contact | Hye Young Kang |
Correspondent | Hye Young Kang i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, Korea, KR 139-845 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-30 |
Decision Date | 2013-12-19 |
Summary: | summary |