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3600
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1733
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2253
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453
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2139
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3627
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3429
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447
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468
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15
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1175
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1624
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805
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473
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82
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698
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4159
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770
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System, Image Processing,...
705
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611
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524
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Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
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Intervertebral Fusion Device...
403
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Mask, Surgical
397
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Prosthesis, Knee,...
350
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Thoracolumbosacral Pedicle Screw...
347
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Manufacturers
US
Intel Corp.
Medical Device Manufacturer
·
US , Folsom , CA
Intel Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intel Corp.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 29, 2010
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
K101178
·
DRG
Cardiovascular
·
63d
Cleared
Nov 26, 2008
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
K083115
·
DRG
Cardiovascular
·
36d
Cleared
Jun 27, 2008
INTEL HEALTH GUIDE, MODEL: PHS6000
K080798
·
DRG
Cardiovascular
·
99d
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3
Cardiovascular
3