Device |
oximeter, infrared, sporting, aviation |
Regulation Description |
Oximeter. |
Definition |
Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise. |
Physical State |
sports watch that emits infrared |
Technical Method |
Non-invasive infrared |
Target Area |
Circulatory pulse |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | OCH |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
Enforcement Discretion
|
Regulation Number |
870.2700
|
Device Class |
2
|
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 |
|
|