510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
NHA
Abutment, Implant, Dental,...
80
MAX
Intervertebral Fusion Device...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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I-Sens, Inc.
Medical Device Manufacturer
·
KR , Seoul
I-Sens, Inc. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2008
27
Total
27
Cleared
0
Denied
26
devices
26-26 of 26
Filters
1
2
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923
·
NBW
Chemistry
·
198d
1
2
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27
Chemistry
26
General & Plastic Surgery
1