The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Kion Anaesthesia System, Model 65 03 879 E392e.
| Device ID | K010923 |
| 510k Number | K010923 |
| Device Name: | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SIEMENS ELEMA AB MEDICAL SOLUTIONS 186 WOOD AVENUE SOUTH Iselin, NJ 08830 -2770 |
| Contact | Diane Wurzburger |
| Correspondent | Diane Wurzburger SIEMENS ELEMA AB MEDICAL SOLUTIONS 186 WOOD AVENUE SOUTH Iselin, NJ 08830 -2770 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2002-01-23 |