21 CFR 868.5560 — Strap, Head, Gas Mask

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5560

Identification

A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

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
BTKStrap, Head, Gas Mask16
Innolitics

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