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510k Database
Manufacturers
US
Irex Corp.
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Medical Device Manufacturer
·
US , Mchenry , IL
Irex Corp. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1977
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irex Corp.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 31, 1985
COLOR DOPPLER 880
K843643
·
DXK
Cardiovascular
·
136d
Cleared
Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246
·
DPW
Cardiovascular
·
99d
Cleared
Dec 27, 1979
IREX CARDIOPLAN
K792525
·
DQK
Cardiovascular
·
21d
Cleared
Aug 04, 1977
SYSTEM II
K771372
·
DSF
Cardiovascular
·
10d
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