The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Assure Prism Multi Blood Glucose Monitoring System.
Device ID | K151164 |
510k Number | K151164 |
Device Name: | Assure Prism Multi 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 137-873 |
Contact | Joon Ho Jung |
Correspondent | Joon Ho Jung i-Sens, Inc. 43, BANPO-DAERO 28-GIL, SEOCHO-GU Seoul, KR 137-873 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-01 |
Decision Date | 2015-08-07 |
Summary: | summary |