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 |