NHP — Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Class II
FDA product code NHP covers "Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)", a Class II medical device regulated under 21 CFR 868.1500. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NHP
- Device Class
- Class II
- Regulation Number
- 868.1500
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040188 | draeger medical systems | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | April 14, 2004 |