The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Oscar(tm) Pb255 Oximeter Capnometer.
| Device ID | K872760 |
| 510k Number | K872760 |
| Device Name: | OSCAR(TM) PB255 OXIMETER CAPNOMETER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Contact | Hannu Ahjopalo |
| Correspondent | Hannu Ahjopalo DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-13 |
| Decision Date | 1987-09-14 |