The following data is part of a premarket notification filed by Bruel & Kjaer Instruments, Inc. with the FDA for Anesthetic Gas Monitor.
| Device ID | K890446 |
| 510k Number | K890446 |
| Device Name: | ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | BRUEL & KJAER INSTRUMENTS, INC. 185 FOREST ST. Marlborough, MA |
| Contact | Aage Ruby |
| Correspondent | Aage Ruby BRUEL & KJAER INSTRUMENTS, INC. 185 FOREST ST. Marlborough, MA |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-08-11 |