The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Pc Care Blood Glucose Data Management Software.
Device ID | K100937 |
510k Number | K100937 |
Device Name: | PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
Contact | Hyun Oh |
Correspondent | Hyun Oh i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-05 |
Decision Date | 2010-12-21 |
Summary: | summary |