The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens N Voice Blood Glucose Monitoring System.
| Device ID | K121133 |
| 510k Number | K121133 |
| Device Name: | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
| 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 | 2012-04-13 |
| Decision Date | 2012-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681131169858 | K121133 | 000 |
| 20681131169817 | K121133 | 000 |
| 10885325000440 | K121133 | 000 |
| 20857513006203 | K121133 | 000 |
| 10857513006190 | K121133 | 000 |
| 20681131285746 | K121133 | 000 |
| 10681131280621 | K121133 | 000 |