K040188 is an FDA 510(k) clearance for the INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE. This device is classified as a Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration) (Class II - Special Controls, product code NHP).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on April 14, 2004, 77 days after receiving the submission on January 28, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1500. A Sevoflurane Gas Analyzer Is A Device Intended To Measure The Concentration Of Sevoflurane Anesthetic In A Gas Mixture.
| 510(k) Number | K040188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2004 |
| Decision Date | April 14, 2004 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHP — Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1500 |
| Definition | A Sevoflurane Gas Analyzer Is A Device Intended To Measure The Concentration Of Sevoflurane Anesthetic In A Gas Mixture |