MAXI-SCOPE OR ULTRA-SCOPE
Device Facts
| Record ID | K912128 |
|---|---|
| Device Name | MAXI-SCOPE OR ULTRA-SCOPE |
| Applicant | Seiichi Mfg., Inc. |
| Product Code | LDE · Cardiovascular |
| Decision Date | Jun 28, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 1 |
Regulatory Classification
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.
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.
