The following data is part of a premarket notification filed by Bruel & Kjaer with the FDA for Carbon Dioxide & Oxygen Monitor Type 1308.
| Device ID | K925484 |
| 510k Number | K925484 |
| Device Name: | CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Contact | Aage Ruby |
| Correspondent | Aage Ruby BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1993-06-22 |