The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Siemens-elema Ab Co2 Monitor 130.
| Device ID | K802459 |
| 510k Number | K802459 |
| Device Name: | SIEMENS-ELEMA AB CO2 MONITOR 130 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SIEMENS ELEMA AB 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-08 |
| Decision Date | 1980-10-23 |