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523
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522
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489
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475
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436
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403
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Manufacturers
US
Heartlab, Inc.
Medical Device Manufacturer
·
US , Providence , RI
Heartlab, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1995
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heartlab, Inc.
Cardiovascular
✕
1
devices
1-1 of 1
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Cleared
Jun 29, 2005
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
K050858
·
DPS
Cardiovascular
·
85d
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6
Radiology
5
Cardiovascular
1