510k
Database
Specialties
Anesthesiology
553
Cardiovascular
1737
Chemistry
387
Dental
1407
Ear, Nose, Throat
258
Gastroenterology & Urology
999
General & Plastic Surgery
2250
General Hospital
2106
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127
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105
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8
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478
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993
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455
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286
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3093
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52
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517
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2520
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
369
FXX
Mask, Surgical
361
GEI
Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
235
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Manufacturers
US
Sensortek, Inc.
Medical Device Manufacturer
·
US , Clifton , NJ
Sensortek, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1984
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sensortek, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 29, 1987
NTE-2 THERMAL SENSITIVITY TESTER
K864345
·
LQW
Neurology
·
86d
Cleared
Dec 03, 1986
VIBRATRON II, VIBRATION SENSITIVITY TESTER
K863607
·
LLN
Neurology
·
78d
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5
Anesthesiology
2
Neurology
2
General Hospital
1