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 CodeDevice NameClassDevicesAttributes
BZSStethoscope Head13
Innolitics

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