21 CFR 868.1870 — Calibrator, Volume, Gas
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1870
Identification
A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.
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 |
|---|---|---|---|---|
| BXW | Calibrator, Volume, Gas | 1 | 6 |
