QSF — Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents Class III
FDA product code QSF covers "Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QSF
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only.