510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1649
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
954
Obstetrics & Gynecology
433
Ophthalmic
274
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2828
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52
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515
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2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Shenzhen Combei Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Guanlan, Shenzhen
Shenzhen Combei Technology Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Combei Technology Co., Ltd.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 29, 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic...
K181104
·
DXN
Cardiovascular
·
125d
Cleared
Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833
·
DXN
Cardiovascular
·
205d
Cleared
May 09, 2017
Digital Blood Pressure Monitor-Automatic Upper Arm Style
K163606
·
DXN
Cardiovascular
·
139d
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4
Cardiovascular
3
General Hospital
1