510k
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Specialties
Anesthesiology
433
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1312
Chemistry
327
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1010
Ear, Nose, Throat
191
Gastroenterology & Urology
782
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1708
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1113
Hematology
117
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83
Medical Genetics
7
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413
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735
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323
Ophthalmic
199
Orthopedic
2374
Pathology
44
Physical Medicine
393
Radiology
1906
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
242
IYN
System, Imaging, Pulsed Doppler,...
233
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
164
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General Electric Medical Systems Information Techn
Medical Device Manufacturer
·
US , Sugarland , TX
General Electric Medical Systems Information Techn - FDA 510(k) Clear...
33 submissions
·
33 cleared
·
Since 1999
33
Total
33
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Electric Medical Systems Information Techn
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 18, 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957
·
DQA
Anesthesiology
·
26d
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33
Cardiovascular
28
Obstetrics & Gynecology
2
Anesthesiology
1
Neurology
1
Radiology
1