510k
Database
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Anesthesiology
505
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1567
Chemistry
355
Dental
1246
Ear, Nose, Throat
230
Gastroenterology & Urology
910
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2084
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1725
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126
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91
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8
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444
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909
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414
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265
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2662
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49
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500
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2263
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154
Categories
GEX
Powered Laser Surgical Instrument
345
LLZ
System, Image Processing,...
345
LZA
Polymer Patient Examination Glove
344
GEI
Electrosurgical, Cutting &...
289
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
FXX
Mask, Surgical
208
NHA
Abutment, Implant, Dental,...
204
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Breathe Technologies
Medical Device Manufacturer
·
US , Alameda , CA
Breathe Technologies - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Breathe Technologies
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 11, 2017
Breathe Technologies Life2000™ Ventilation System
K170037
·
CBK
Anesthesiology
·
219d
Cleared
Jun 12, 2015
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
K141943
·
CBK
Anesthesiology
·
330d
Cleared
Mar 06, 2014
BREATHE NIOV VENTILATION SYSTEM
K131562
·
ONZ
Anesthesiology
·
280d
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3
Anesthesiology
3