Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K160365
Device Name BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
Applicant
Infopia Co., Ltd.
132, Anyangcheondong-ro, Dongan-gu
Anyang,  KR 14040
Applicant Contact NA YUN KIM
Correspondent
LK Consulting Group USA, Inc.
800 ROOSEVELT STE 417
IRVINE,  CA  92620
Correspondent Contact PRISCILLA CHUNG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received02/09/2016
Decision Date 09/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-