Device |
plethysmograph, ocular |
Regulation Description |
Ocular plethysmograph. |
Definition |
PMAs to be filed by 9/21/04 (69 FR 34920 (6/23/04)) |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | JXF |
Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
PMA
|
Regulation Number |
882.1790
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|