510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
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1304
Ear, Nose, Throat
237
Gastroenterology & Urology
933
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2140
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1991
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126
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91
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8
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449
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942
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429
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272
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2739
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52
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515
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2354
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
265
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Respironics Georgia, Inc.
Medical Device Manufacturer
·
US , Marietta , GA
Respironics Georgia, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2001
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Respironics Georgia, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 11, 2002
SMARTMONITOR 2, MODEL 4000
K011597
·
FLS
Anesthesiology
·
232d
Cleared
Mar 01, 2001
PROFOX SOFTWARE, MODEL 920M-41
K001708
·
DQA
Anesthesiology
·
269d
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Anesthesiology
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