510k
Database
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Anesthesiology
505
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1567
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355
Dental
1246
Ear, Nose, Throat
230
Gastroenterology & Urology
910
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2084
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1725
Hematology
126
Immunology
91
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8
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444
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909
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414
Ophthalmic
265
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2662
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49
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500
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2263
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154
Categories
GEX
Powered Laser Surgical Instrument
345
LLZ
System, Image Processing,...
345
LZA
Polymer Patient Examination Glove
344
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Electrosurgical, Cutting &...
289
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
FXX
Mask, Surgical
208
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Abutment, Implant, Dental,...
204
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Respiratory Motion, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Respiratory Motion, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2012
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Respiratory Motion, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 16, 2018
ExSpiron 1Xi
K173181
·
BZK
Anesthesiology
·
168d
Cleared
May 09, 2017
ExSpiron 1Xi
K162131
·
BZK
Anesthesiology
·
281d
Cleared
May 29, 2013
EXSPIRON 1XI
K130170
·
BZK
Anesthesiology
·
125d
Cleared
Sep 26, 2012
EXSPIRON
K120087
·
BZK
Anesthesiology
·
259d
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4
Anesthesiology
4