QBE · Cranial Sound Monitor
Cardiovascular · 21 CFR 870.1875 · Class 2
Overview
| Product Code | QBE |
|---|---|
| Device Name | Cranial Sound Monitor |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
Classification Rationale
Manual stethoscope: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. Electronic stethoscope: Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172892 | Neuro Assessment System NAS-1000 | Headsense Medical, Inc. | Mar 8, 2018 | SESE |
Top Applicants
- Headsense Medical, Inc. — 1 clearance
