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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTK | Strap, Head, Gas Mask | 1 | 6 |