510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1621
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
940
General & Plastic Surgery
2143
General Hospital
2013
Hematology
126
Immunology
91
Medical Genetics
8
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458
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942
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429
Ophthalmic
272
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2757
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52
Physical Medicine
515
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2355
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
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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Sleep Solutions, Inc.
Medical Device Manufacturer
·
US , Burlingame , CA
Sleep Solutions, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1998
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sleep Solutions, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 16, 2000
SILENT NIGHT V
K000253
·
MNR
Anesthesiology
·
294d
Cleared
Oct 30, 1998
SILENT NIGHT II
K981034
·
MNR
Anesthesiology
·
225d
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Anesthesiology
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