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510k Database
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CA
Xltek
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Medical Device Manufacturer
·
CA , Oakville
Xltek - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Xltek
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 14, 2002
84 CHANNEL EEG
K014146
·
GWQ
Neurology
·
27d
Cleared
Jan 14, 2002
80 CHANNEL EEG
K014147
·
GWQ
Neurology
·
27d
Cleared
Dec 08, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969
·
GWF
Neurology
·
77d
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Neurology
3