The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Anesthesia Gas Monitor, Model M1026b.
| Device ID | K040917 |
| 510k Number | K040917 |
| Device Name: | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Herbert Van Dyk |
| Correspondent | Herbert Van Dyk PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838010055 | K040917 | 000 |
| 00884838010024 | K040917 | 000 |
| 20884838010646 | K040917 | 000 |
| 20884838010042 | K040917 | 000 |
| 20884838010035 | K040917 | 000 |