The following data is part of a premarket notification filed by Bruel & Kjaer with the FDA for Anesthetic Gas Monitor Type 1304, Modified.
| Device ID | K914295 |
| 510k Number | K914295 |
| Device Name: | ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| 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 | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-09 |
| Decision Date | 1992-04-10 |