510k
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1134
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4610
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3346
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2794
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469
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2452
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4190
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3857
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808
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796
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15
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1914
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1773
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890
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497
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7871
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167
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963
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4789
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1242
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System, Image Processing,...
730
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696
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570
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
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Screw, Fixation, Bone
401
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Manufacturers
US
Neurometrics
Medical Device Manufacturer
·
US , Mchenry , IL
Neurometrics - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1980
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neurometrics
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 25, 1986
LIFESCAN EVOKED POTENTIAL SYSTEM
K861900
·
GWF
Neurology
·
101d
Cleared
Jul 12, 1984
LIFESCAN EEG MONITOR
K841790
·
OLT
Neurology
·
73d
Cleared
Apr 02, 1980
NEUROMETRICS MONITOR
K800452
·
GWS
Neurology
·
34d
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3
Neurology
3