The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Airway Module.
| Device ID | K943458 |
| 510k Number | K943458 |
| Device Name: | AS/3 AIRWAY MODULE |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki, FI |
| Contact | Vincent Rauscher |
| Correspondent | Vincent Rauscher DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki, FI |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1995-02-14 |