510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1584
Chemistry
355
Dental
1274
Ear, Nose, Throat
233
Gastroenterology & Urology
922
General & Plastic Surgery
2109
General Hospital
1856
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
926
Obstetrics & Gynecology
420
Ophthalmic
266
Orthopedic
2678
Pathology
50
Physical Medicine
506
Radiology
2290
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
381
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
270
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Respironics Inc., Sleep & Home Respiratory Group
Medical Device Manufacturer
·
US , Murrysville , PA
Respironics Inc., Sleep & Home Respiratory Group - FDA 510(k) Cleared...
21 submissions
·
21 cleared
·
Since 2007
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Respironics Inc., Sleep & Home Respiratory Group
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
May 18, 2007
WALLABY 4
K070180
·
LBI
General Hospital
·
119d
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21
Anesthesiology
20
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1