21 CFR 868.5975 — Set, Tubing And Support, Ventilator (W Harness)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5975

Identification

Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

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
BZOSet, Tubing And Support, Ventilator (W Harness)188
Innolitics

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