21 CFR 868.1500 — Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1500
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 22 | 3rd Party |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 0 | 3rd Party |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 1 | 3rd Party |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 0 | 3rd Party |
