| Device |
impedance plethysmograph, cranial |
| Regulation Description |
Impedance plethysmograph. |
| Definition |
Detect or measure variations in volume in the cranium, using tissue impedance properties. |
| Physical State |
Device has emitter(s), receiver(s), and computational capacity to analyze signals. Signals may be transmitted with electrical current, radio frequency, or other means affected by tissue impedance. |
| Technical Method |
An emitter sends a signal through the cranium. Cranial tissues have a natural electrical impedance that will alter this signal as it passes through them. The altered signal is detected/recorded with a receiver. Analysis of the signal alterations yield information about volumetric changes. |
| Target Area |
Cranium |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Neurology |
|---|
| Product Code | QAF |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2770
|
|---|
| Device Class |
2
|
| 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 |
