The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Modification To Kion Anesthesia System.
| Device ID | K001315 |
| 510k Number | K001315 |
| Device Name: | MODIFICATION TO KION ANESTHESIA SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | SIEMENS ELEMA AB ELECTROMEDICAL SYSTEMS GROUP 16 ELECTRONICS AVENUE Danvers, MA 01923 |
| Contact | Dave Simard |
| Correspondent | Dave Simard SIEMENS ELEMA AB ELECTROMEDICAL SYSTEMS GROUP 16 ELECTRONICS AVENUE Danvers, MA 01923 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-05-26 |