510k
Database
Specialties
Anesthesiology
6740
Cardiovascular
15499
Chemistry
11510
Dental
10464
Ear, Nose, Throat
2887
Gastroenterology & Urology
8179
General & Plastic Surgery
14669
General Hospital
12976
Hematology
2726
Immunology
3217
Medical Genetics
20
Microbiology
6047
Neurology
5174
Obstetrics & Gynecology
3518
Ophthalmic
3230
Orthopedic
17114
Pathology
902
Physical Medicine
3372
Radiology
13362
Toxicology
2735
Categories
Powered Laser Surgical Instrument
GEX
2547
System, Image Processing, Radiological
LLZ
2149
Electrosurgical, Cutting &...
GEI
2023
Implant, Endosseous, Root-form
DZE
1376
Plate, Fixation, Bone
HRS
1306
Laparoscope, General & Plastic Surgery
GCJ
1172
Polymer Patient Examination Glove
LZA
1161
System, Imaging, Pulsed Doppler,...
IYN
1158
System, Nuclear Magnetic Resonance...
LNH
1022
Screw, Fixation, Bone
HWC
1019
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
KR
I-Sens, Inc.
Share
Medical Device Manufacturer
·
KR , Seoul
I-Sens, Inc. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 2008
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Dec 21, 2010
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937
·
NBW
Chemistry
·
260d
Cleared
Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468
·
NBW
Chemistry
·
78d
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923
·
NBW
Chemistry
·
198d
1
2
Filters
Filter by Specialty
All
28
Chemistry
27
General & Plastic Surgery
1