The following data is part of a premarket notification filed by Dalton Instrument Corp. with the FDA for Oscar(tm) Ii Capnometer & Pulse Oximeter.
| Device ID | K904843 |
| 510k Number | K904843 |
| Device Name: | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER |
| Classification | Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) |
| Applicant | DALTON INSTRUMENT CORP. P.O. BOX 357 SF-00101 Helsinki, Finland, FI |
| Contact | Rauno Ruoho |
| Correspondent | Rauno Ruoho DALTON INSTRUMENT CORP. P.O. BOX 357 SF-00101 Helsinki, Finland, FI |
| Product Code | CBR |
| CFR Regulation Number | 868.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-25 |
| Decision Date | 1991-04-09 |