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510k Database
Manufacturers
US
Spectralmd, Inc.
Medical Device Manufacturer
·
US , Richardson , TX
Spectralmd, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 2013
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Spectralmd, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 17, 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
K163339
·
DPT
Cardiovascular
·
262d
Cleared
Apr 18, 2013
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
K124049
·
DPT
Cardiovascular
·
108d
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Cardiovascular
2
General & Plastic Surgery
1