21 CFR 868.1575 — Gas, Collecting Vessel
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1575
Identification
A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.
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 |
|---|---|---|---|---|
| KGK | Gas, Collecting Vessel | 1 | 2 |
