510k
Database
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Anesthesiology
542
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1683
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369
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1339
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249
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977
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2198
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2048
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126
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99
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8
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469
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965
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436
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279
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2944
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52
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515
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2446
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Imsonic Medical China, Inc.
Medical Device Manufacturer
·
CN , Kunshan
Imsonic Medical China, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Imsonic Medical China, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 11, 2022
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983
·
IYN
Radiology
·
221d
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Radiology
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