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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

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]

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

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]