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U.S. Department of Health and Human Services

Product Classification
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Device cranial sound monitor
Regulation Description Stethoscope.
Definition To non-invasively detect, monitor, record and display acoustic signals in the brain.
Physical State Acoustic recording hardware and signal processing software. The device may include a headset to be placed in the ear. The device may include hardware and software to allow for data collection and review. The device does not include software that outputs any clinical interpretation of the data.
Technical Method An audio recorder headphone is placed into the ear to detect acoustic sounds of the brain / cranium, which are transmitted to hardware that processes and displays these sounds.
Target Area Head
Regulation Medical Specialty Cardiovascular
Review Panel Neurology
Product CodeQBE
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 870.1875
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
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