The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Capnomac Ultima (tm) Anesthesia Monitor.
| Device ID | K903104 |
| 510k Number | K903104 |
| Device Name: | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Contact | Olli Riikkala |
| Correspondent | Olli Riikkala DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, 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 | 1990-07-13 |
| Decision Date | 1991-01-23 |