510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2126
General Hospital
1959
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
938
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2691
Pathology
52
Physical Medicine
511
Radiology
2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Vivosonic, Inc.
Medical Device Manufacturer
·
US , Stamford , CT
Vivosonic, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2001
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vivosonic, Inc.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 19, 2024
Integrity V500 (Integrity, Integrity with VEMP)
K242954
·
GWJ
Ear, Nose, Throat
·
85d
Cleared
Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108
·
EWO
Ear, Nose, Throat
·
27d
Cleared
Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364
·
EWO
Ear, Nose, Throat
·
264d
Filters
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5
Ear, Nose, Throat
3
Neurology
2