510k
Database
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Anesthesiology
452
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1378
Chemistry
334
Dental
1067
Ear, Nose, Throat
196
Gastroenterology & Urology
816
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1803
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1236
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122
Immunology
85
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7
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420
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769
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339
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215
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2429
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45
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414
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1989
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143
Categories
GEX
Powered Laser Surgical Instrument
294
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
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Automated Radiological Image...
252
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
208
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Aspect Electronics, Inc.
Medical Device Manufacturer
·
US , San Leandro , CA
Aspect Electronics, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1995
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aspect Electronics, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 23, 1996
ASPECT OPTICAM
K962051
·
LMC
Radiology
·
87d
Cleared
Jan 02, 1996
ASPECT ACQUISITION MODULE (AAM)
K954875
·
LMA
Radiology
·
70d
Cleared
Nov 13, 1995
ASPECT DIGITAL FORMATTER
K954149
·
LMC
Radiology
·
69d
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3
Radiology
3