510k
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505
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1571
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1249
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232
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910
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2085
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1732
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126
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91
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444
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2663
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501
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154
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Polymer Patient Examination Glove
345
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Powered Laser Surgical Instrument
345
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System, Image Processing,...
345
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Electrosurgical, Cutting &...
289
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Automated Radiological Image...
271
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System, Imaging, Pulsed Doppler,...
263
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Plate, Fixation, Bone
260
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Orthopedic Stereotaxic Instrument
217
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Mask, Surgical
213
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Abutment, Implant, Dental,...
204
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Oxyheal Medical Systems, Inc.
Medical Device Manufacturer
·
US , National City , CA
Oxyheal Medical Systems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oxyheal Medical Systems, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 22, 2017
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
K163109
·
CBF
Anesthesiology
·
135d
Cleared
Apr 29, 2016
Rectangular Multiplace Hyperbaric Chamber System Product Family with...
K152223
·
CBF
Anesthesiology
·
266d
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Anesthesiology
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