510k
Database
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Anesthesiology
510
Cardiovascular
1584
Chemistry
355
Dental
1276
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2111
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1861
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126
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91
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8
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449
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930
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420
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266
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2680
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50
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507
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2293
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
384
LLZ
System, Image Processing,...
357
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
271
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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MyCardio, LLC
Medical Device Manufacturer
·
US , Broomfield , CO
MyCardio, LLC - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2009
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - MyCardio, LLC
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 30, 2009
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
K092003
·
MNR
Anesthesiology
·
90d
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Anesthesiology
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