510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1583
Chemistry
355
Dental
1272
Ear, Nose, Throat
233
Gastroenterology & Urology
921
General & Plastic Surgery
2108
General Hospital
1845
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
925
Obstetrics & Gynecology
420
Ophthalmic
265
Orthopedic
2677
Pathology
50
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
378
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
265
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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Atlantean
Medical Device Manufacturer
·
US , Bonita Springs , FL
Atlantean - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2010
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Atlantean
Anesthesiology
✕
1
devices
1-1 of 1
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Cleared
Sep 20, 2010
MODEL SB100II FINGER PULSE OXIMETER
K101568
·
DQA
Anesthesiology
·
110d
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1
Anesthesiology
1