NHP · Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Anesthesiology · 21 CFR 868.1500 · Class 2
Overview
| Product Code | NHP |
|---|---|
| Device Name | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Regulation | 21 CFR 868.1500 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040188 | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | Draeger Medical Systems, Inc. | Apr 14, 2004 | SESE |
Top Applicants
- Draeger Medical Systems, Inc. — 1 clearance
