The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for As/3 Anaesthesia Monitoring System Airway Module.
| Device ID | K923433 |
| 510k Number | K923433 |
| Device Name: | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Contact | Seppo Luode |
| Correspondent | Seppo Luode INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Product Code | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1993-07-22 |