Thermogear, Inc. is one of 23530 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Thermogear, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002, CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002, CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
3
Total
3
Cleared
0
Denied
Thermogear, Inc. has 3 FDA 510(k) cleared medical devices. Based in Lake Oswego, US.
Historical record: 3 cleared submissions from 2000 to 2008. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Thermogear, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Thermogear, Inc.
3 devices