868.5770—Tracheal tube fixation device.
(a) Identification.
A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.
(b) Classification.
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.