CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA

System, Test, Blood Glucose, Over The Counter

I-SENS, Inc.

The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca.

Pre-market Notification Details

• Device ID: K120351
• 510k Number: K120351
• Device Name: CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: i-SENS, Inc. 465-6 WOLGYE4-DONG, NOWON-GU Seoul, KR 139-845
• Contact: Hyun Joon Oh
• Correspondent: Hyun Joon Oh; i-SENS, Inc. 465-6 WOLGYE4-DONG, NOWON-GU Seoul, KR 139-845
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-06
• Decision Date: 2012-05-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30015482541997	K120351	000
10875011000304	K120351	000