21 CFR 868.1930 — Stethoscope Head
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1930
Identification
A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.
Classification Rationale
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 § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZS | Stethoscope Head | 1 | 3 |