510k
Database
Specialties
Anesthesiology
203
Cardiovascular
732
Chemistry
187
Dental
459
Ear, Nose, Throat
88
Gastroenterology & Urology
390
General & Plastic Surgery
763
General Hospital
470
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
274
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295
Obstetrics & Gynecology
114
Ophthalmic
76
Orthopedic
1472
Pathology
26
Physical Medicine
152
Radiology
1079
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
165
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
GEX
Powered Laser Surgical Instrument
123
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Shenzhen Carewell Electronics Co., Ltd.
Medical Device Manufacturer
·
CN , Shanghai
Shenzhen Carewell Electronics Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 20, 2020
AI-ECG Tracker
K200036
·
DPS
Cardiovascular
·
72d
Cleared
Apr 25, 2012
ELECTROCARDIOGRAPH
K113485
·
DPS
Cardiovascular
·
154d
Filters
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2
Cardiovascular
2