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 Code | QBE |
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 |