510k
Database
Specialties
Anesthesiology
506
Cardiovascular
1577
Chemistry
355
Dental
1263
Ear, Nose, Throat
233
Gastroenterology & Urology
911
General & Plastic Surgery
2093
General Hospital
1774
Hematology
126
Immunology
91
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8
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445
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916
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417
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265
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2672
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49
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502
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2278
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154
Categories
LZA
Polymer Patient Examination Glove
355
LLZ
System, Image Processing,...
348
GEX
Powered Laser Surgical Instrument
346
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
232
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Apnicure, Inc.
Medical Device Manufacturer
·
US , Redwood City , CA
Apnicure, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2012
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Apnicure, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 13, 2014
WINX SLEEP THERAPY SYSTEM
K132003
·
OZR
Anesthesiology
·
347d
Cleared
May 22, 2013
WINX SLEEP THERAPY SYSTEM
K130538
·
OZR
Anesthesiology
·
82d
Cleared
Oct 31, 2012
WINX SLEEP THERAPY SYSTEM
K122130
·
OZR
Anesthesiology
·
105d
Cleared
Mar 30, 2012
ATTUNE SLEEP APNEA SYSTEM
K111549
·
OZR
Anesthesiology
·
301d
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4
Anesthesiology
4