The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap Ii Cg-2gs, 2g, 1gs, 1g, 2cg, Cs Monitor.
| Device ID | K902493 |
| 510k Number | K902493 |
| Device Name: | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR |
| Classification | Monitor, Line Isolation |
| 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 | DRI |
| CFR Regulation Number | 870.2620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-07-06 |