The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Ab O2 Consumption Calculator 980.
| Device ID | K802417 |
| 510k Number | K802417 |
| Device Name: | AB O2 CONSUMPTION CALCULATOR 980 |
| Classification | Computer, Oxygen-uptake |
| Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-10-23 |