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Manufacturers
US
Heart Sync, LLC
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Medical Device Manufacturer
·
US , Ann Arbor , MI
Heart Sync, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2008
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heart Sync, LLC
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 24, 2008
HEART SYNC PEDIATRIC, MODEL PED-100
K081442
·
LDD
Cardiovascular
·
125d
Cleared
Feb 29, 2008
HEART SYNC, MODELS C-100 AND T-100
K080421
·
MKJ
Cardiovascular
·
14d
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Cardiovascular
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