510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1578
Chemistry
355
Dental
1267
Ear, Nose, Throat
233
Gastroenterology & Urology
918
General & Plastic Surgery
2100
General Hospital
1816
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
446
Neurology
921
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2674
Pathology
49
Physical Medicine
504
Radiology
2287
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
370
LLZ
System, Image Processing,...
355
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
291
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
250
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Koo (Shanghai) Industries Co., Ltd.
Medical Device Manufacturer
·
US , Bonita Springs , FL
Koo (Shanghai) Industries Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Koo (Shanghai) Industries Co., Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 22, 2011
KOO SMALL VOLUME NEBULIZER (SVN)
K112041
·
CAF
Anesthesiology
·
157d
Cleared
Jan 28, 2011
FISIO CHAMBER SPACE
K101136
·
NVP
Anesthesiology
·
281d
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Anesthesiology
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