The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution.
| Device ID | K103396 |
| 510k Number | K103396 |
| Device Name: | COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | i-SENS, Inc. 100 GARDEN CITY PLAZA, SITE 412B Garden City, NY 11530 |
| Contact | Stanley R Goodman |
| Correspondent | Stanley R Goodman i-SENS, Inc. 100 GARDEN CITY PLAZA, SITE 412B Garden City, NY 11530 |
| 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 | 2010-11-19 |
| Decision Date | 2011-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885325000812 | K103396 | 000 |
| 20885325000768 | K103396 | 000 |
| 20885325000751 | K103396 | 000 |
| 20885325000379 | K103396 | 000 |