MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

The following data is part of a premarket notification filed by Tianjin Empecs Medical Device Co., Ltd. with the FDA for Medisign Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK111456
510k NumberK111456
Device Name:MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TIANJIN EMPECS MEDICAL DEVICE CO., LTD. RM 1301, GYEONGGI VENT. ANYANG SCI UNIV., 572-5 ANYANG 8-DONG Manan-gu Anyang-si Gyeonggi-do,  KR 430-731
ContactHl Jung
CorrespondentHl Jung
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. RM 1301, GYEONGGI VENT. ANYANG SCI UNIV., 572-5 ANYANG 8-DONG Manan-gu Anyang-si Gyeonggi-do,  KR 430-731
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-25
Decision Date2012-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10370393211053 K111456 000
00383568100727 K111456 000
10383568100731 K111456 000
10383568100748 K111456 000
00383568100758 K111456 000
10673486000719 K111456 000
20888277409184 K111456 000
20888277409177 K111456 000
10888277409163 K111456 000
00854067005191 K111456 000
10370393210209 K111456 000
00383568100710 K111456 000

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