21 CFR 868.5530 — Laryngoscope, Non-Rigid
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5530
Identification
A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
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 |
|---|---|---|---|---|
| CAL | Laryngoscope, Non-Rigid | 1 | 8 |