Definition: Detect Or Measure Variations In Volume In The Cranium, Using Tissue Impedance Properties.
| Device Type ID | 3633 |
| Device Name | Impedance Plethysmograph, Cranial |
| 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 Yiel |
| Target Area | Cranium |
| Regulation Description | Impedance Plethysmograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3633 |
| Device | Impedance Plethysmograph, Cranial |
| Product Code | QAF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |