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2077
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1950
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1292
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1144
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1140
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Polymer Patient Examination Glove
1100
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1004
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992
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510k Database
Manufacturers
US
Eigen Video
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Medical Device Manufacturer
·
US , Nevada City , CA
Eigen Video - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1985
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eigen Video
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 24, 1994
DIGITAL MEDIA CONVERTER (D-MC)
K935026
·
IZI
Radiology
·
308d
Cleared
Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264
·
JAA
Radiology
·
72d
Cleared
Apr 19, 1985
DIGITAL IMAGE PROCESSOR FP-2C
K850080
·
LLZ
Radiology
·
99d
Cleared
Mar 26, 1985
EIGEN FLORO-STOR FS-100
K844375
·
JAA
Radiology
·
133d
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4
Radiology
4