The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model Gm5051a Or Gm5051b Or Gm5051c (color).
| Device ID | K083468 |
| 510k Number | K083468 |
| Device Name: | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
| Contact | Hyun Joon Oh |
| Correspondent | Hyun Joon Oh i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885325000112 | K083468 | 000 |
| 10885325000051 | K083468 | 000 |
| 10885325000044 | K083468 | 000 |
| 20885325000027 | K083468 | 000 |
| 10885325000013 | K083468 | 000 |
| 30015482542994 | K083468 | 000 |