The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens Blood Glucose Monitoring System; Caresens Ii Meter, Model Gm505c; Caresens Pop Meter, Model Gm505ea Or Gm505eb.
| Device ID | K080923 |
| 510k Number | K080923 |
| Device Name: | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-10-17 |
| Summary: | summary |