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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 88 |