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 |