510k
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Anesthesiology
542
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1683
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370
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1341
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250
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979
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2201
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2052
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126
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99
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8
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472
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969
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436
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279
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2961
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52
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515
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2457
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Comper Chuangxiang (Beijing) Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Daxing District
Comper Chuangxiang (Beijing) Technology Co., Ltd. - FDA 510(k) Cleare...
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Comper Chuangxiang (Beijing) Technology Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 28, 2021
ThermArt (Model IR-EFT)
K202481
·
FLL
General Hospital
·
396d
Cleared
Oct 18, 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668
·
FLL
General Hospital
·
119d
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General Hospital
2