510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
317
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
233
Neurology
171
Obstetrics & Gynecology
62
Ophthalmic
50
Orthopedic
1295
Pathology
18
Physical Medicine
87
Radiology
871
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
Browse all 339 categories →
Search
Reports
About
Home
Atsens Co., Ltd.
Medical Device Manufacturer
·
KR , Seongnam-Si
Atsens Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Atsens Co., Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583
·
DSH
Cardiovascular
·
245d
Cleared
Oct 12, 2022
AT-Patch ECG Analysis System
K203638
·
DSH
Cardiovascular
·
667d
Filters
Filter by Specialty
All
2
Cardiovascular
2