The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Anesthetic Agent Monitor.
| Device ID | K892854 |
| 510k Number | K892854 |
| Device Name: | ANESTHETIC AGENT MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Contact | Der Ruhr |
| Correspondent | Der Ruhr CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Product Code | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-10-13 |