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U.S. Department of Health and Human Services

Product Classification

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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 CodeQAF
Premarket Review 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible