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Manufacturers
US
Thermogear, Inc.
Medical Device Manufacturer
·
US , Lake Oswego , OR
Thermogear, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thermogear, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 31, 2008
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
K083135
·
DWJ
Cardiovascular
·
8d
Cleared
Nov 09, 2007
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
K071918
·
DWJ
Cardiovascular
·
120d
Cleared
Mar 01, 2000
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
K991684
·
DWJ
Cardiovascular
·
289d
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Cardiovascular
3