510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1333
Ear, Nose, Throat
244
Gastroenterology & Urology
958
General & Plastic Surgery
2183
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2868
Pathology
52
Physical Medicine
515
Radiology
2428
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Ectosense NV
Medical Device Manufacturer
·
BE , Rotselaar
Ectosense NV - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
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
Mar 06, 2020
NightOwl
K191031
·
MNR
Anesthesiology
·
323d
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3
Anesthesiology
3