K040917 is an FDA 510(k) clearance for the PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B. This device is classified as a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II - Special Controls, product code CBQ).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on April 29, 2004, 21 days after receiving the submission on April 8, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1500.
| 510(k) Number | K040917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2004 |
| Decision Date | April 29, 2004 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBQ — Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1500 |