Submission Details
| 510(k) Number | K040917 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
Apr 2004
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K040917 is an FDA 510(k) clearance for the PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B, 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 review panel. Regulated under 21 CFR 868.1500.
Device Classification
| Product Code | CBQ — Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1500 |
Manufacturer
Philips Medizin Systeme Boeblingen GmbH
Boeblingen, Baden-Wuerttemberg · DE
HERBERT VAN DYK
48 submissions
48 cleared
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