510k
Database
Specialties
Anesthesiology
544
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1689
Chemistry
370
Dental
1347
Ear, Nose, Throat
250
Gastroenterology & Urology
979
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2204
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2052
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126
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100
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8
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472
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975
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437
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280
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2977
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52
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515
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2463
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
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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
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Hunan Accurate Bio-Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Changsha, Hunan
Hunan Accurate Bio-Medical Technology Co., Ltd. - FDA 510(k) Cleared ...
5 submissions
·
5 cleared
·
Since 2014
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hunan Accurate Bio-Medical Technology Co., Ltd.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 02, 2025
Pulse Oximeter (FS20P)
K243049
·
DQA
Anesthesiology
·
97d
Cleared
Oct 03, 2024
Pulse Oximeter (WS20A)
K240808
·
DQA
Anesthesiology
·
192d
Cleared
Mar 27, 2018
Pulse Oximeter
K171241
·
DQA
Anesthesiology
·
334d
Cleared
Dec 04, 2014
PULSE OXIMETER
K141105
·
DQA
Anesthesiology
·
219d
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5
Anesthesiology
4
Gastroenterology & Urology
1