Device |
system, telethermographic, infrared |
Regulation Description |
Telethermographic system. |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Radiology |
Product Code | IYM |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
PMA
|
Regulation Number |
884.2980
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|