Device |
doppler, fetal, ultrasound |
Regulation Description |
Fetal ultrasonic monitor and accessories. |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Radiology |
Product Code | LXE |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
510(k)
|
Regulation Number |
884.2660
|
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
|
Accredited Persons
|
|
|