510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1495
Chemistry
343
Dental
1179
Ear, Nose, Throat
216
Gastroenterology & Urology
860
General & Plastic Surgery
1942
General Hospital
1496
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
850
Obstetrics & Gynecology
370
Ophthalmic
251
Orthopedic
2567
Pathology
49
Physical Medicine
455
Radiology
2127
Toxicology
148
Categories
GEX
Powered Laser Surgical Instrument
317
LLZ
System, Image Processing,...
314
LZA
Polymer Patient Examination Glove
287
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
256
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
199
MAX
Intervertebral Fusion Device...
179
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O'Tec Corp.
Medical Device Manufacturer
·
US , Oberlin , KS
O'Tec Corp. - FDA 510(k) Cleared Devices
23 submissions
·
18 cleared
·
Since 1988
23
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - O'Tec Corp.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 19, 1994
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293
·
IOR
Physical Medicine
·
42d
Cleared
Aug 02, 1988
WHEELCHAIR BCW 6000
K883034
·
IOR
Physical Medicine
·
14d
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23
Orthopedic
21
Physical Medicine
2