KGK · Gas, Collecting Vessel
Anesthesiology · 21 CFR 868.1575 · Class 1
Overview
| Product Code | KGK |
|---|---|
| Device Name | Gas, Collecting Vessel |
| Regulation | 21 CFR 868.1575 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863171 | RESPIRONICS PROTECTEASY | Respironics, Inc. | Oct 15, 1986 | SESE |
| K770632 | GAS COLLHCTOR BE 155(155-2-3,154-4) | Instrumentation Industries, Inc. | Apr 8, 1977 | SESE |
Top Applicants
- Respironics, Inc. — 1 clearance
- Instrumentation Industries, Inc. — 1 clearance
