510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2729
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
264
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Itamar Medical (C.M.) 1997 , Ltd.
Medical Device Manufacturer
·
IL , Ginot Shomron 44853
Itamar Medical (C.M.) 1997 , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 19, 2002
SLEEP PAT 200 DEVICE
K010156
·
MNR
Anesthesiology
·
519d
Cleared
Nov 06, 2001
WATCH-PAT 100
K010739
·
MNR
Anesthesiology
·
239d
Filters
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3
Anesthesiology
2
Cardiovascular
1