The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Glucocard Shine Connex Blood Glucose Monitoring System, Glucocard Shine Express Blood Glucose Monitoring System.
Device ID | K181273 |
510k Number | K181273 |
Device Name: | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | i-SENS, Inc. 43, Banpo-daero 82-gil, Seocho-gu Seoul, KR 06646 |
Contact | Joon Ho Jung |
Correspondent | Joon Ho Jung i-SENS, Inc. 43, Banpo-daero 82-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 | 2018-05-14 |
Decision Date | 2018-11-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10885325001768 | K181273 | 000 |