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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
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Impedance Plethysmograph, Cranial
- Page Type
- Product Code
- 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
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 870.2770
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 870.2770 Impedance plethysmograph
§ 870.2770 Impedance plethysmograph.
(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]