The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Normac Anesthetic Agent Monitor.
| Device ID | K832113 |
| 510k Number | K832113 |
| Device Name: | NORMAC ANESTHETIC AGENT MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 357 SF-00101 Helsinki 10 Finland , |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-30 |
| Decision Date | 1983-09-12 |