510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
934
General & Plastic Surgery
2142
General Hospital
2009
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
406
LLZ
System, Image Processing,...
374
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
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Neotonus, Inc.
Medical Device Manufacturer
·
US , North Attleboro , MA
Neotonus, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1998
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neotonus, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 29, 2000
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903
·
KPI
Gastroenterology & Urology
·
68d
Cleared
Jun 12, 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096
·
KPI
Gastroenterology & Urology
·
297d
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4
Gastroenterology & Urology
2
Physical Medicine
1
Anesthesiology
1