CareSens S Clear BT Blood Glucose Monitoring System

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 S Clear Bt Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K192859
• 510k Number: K192859
• Device Name: CareSens S Clear BT Blood Glucose Monitoring System
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul, KR 06646
• Contact: Joon Ho Jung
• Correspondent: Joon Ho Jung; i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul, KR 06646
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-04
• Decision Date: 2020-01-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885325001423	K192859	000
10885325001416	K192859	000
10885325001409	K192859	000
10885325001386	K192859	000