OCR · Lung Sound Monitor
Cardiovascular · 21 CFR 870.1875 · Class 2
Overview
| Product Code | OCR |
|---|---|
| Device Name | Lung 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091732 | VRLXP, MODEL XP | Deep Breeze , Ltd. | Mar 4, 2010 | SESE |
| K073582 | VRIICU SYSTEM | Deep Breeze , Ltd. | Oct 15, 2008 | SESE |
| K061495 | VR LUNG ELECTROSONOGRAPH | Deep Breeze , Ltd. | Jul 18, 2007 | SESE |
Top Applicants
- Deep Breeze , Ltd. — 3 clearances
