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535
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522
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494
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465
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448
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510k Database
Manufacturers
BE
Ectosense NV
Medical Device Manufacturer
·
BE , Rotselaar
Ectosense NV - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
Recent clearances:
NightOwl
,
NightOwl
,
NightOwl
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ectosense NV
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
CT
Feb 24, 2022
NightOwl
K220028
·
MNR
Anesthesiology
·
50d
Cleared
Dec 16, 2021
NightOwl
K213463
·
MNR
Anesthesiology
·
50d
Cleared
CT
Mar 06, 2020
NightOwl
K191031
·
MNR
Anesthesiology
·
323d
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Anesthesiology
3