510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1572
Chemistry
355
Dental
1253
Ear, Nose, Throat
233
Gastroenterology & Urology
910
General & Plastic Surgery
2087
General Hospital
1740
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
914
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2666
Pathology
49
Physical Medicine
501
Radiology
2269
Toxicology
154
Categories
LLZ
System, Image Processing,...
347
LZA
Polymer Patient Examination Glove
346
GEX
Powered Laser Surgical Instrument
345
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
219
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Jiang Su
Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. - FDA 510(...
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 18, 2016
Fingertip Pulse Oximeter
K152091
·
DQA
Anesthesiology
·
388d
Cleared
Aug 17, 2016
Wrist Pulse Oximeter
K152089
·
DQA
Anesthesiology
·
387d
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Anesthesiology
2