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 |