The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Siemens O2-air Mixer 965.
| Device ID | K872278 |
| 510k Number | K872278 |
| Device Name: | SIEMENS O2-AIR MIXER 965 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Contact | Ellen Farney |
| Correspondent | Ellen Farney SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-15 |
| Decision Date | 1987-09-03 |