510(k) K040188
K040188 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE". The FDA issued a decision of Substantially Equivalent on April 14, 2004. The device falls under product code NHP (Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2004
- Date Received
- January 28, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- Device Class
- Class II
- Regulation Number
- 868.1500
- Review Panel
- AN
- Submission Type
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture