The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap Ii Monitors: Ch, Ch-2, Ch-s, Ch-2s.
| Device ID | K902492 |
| 510k Number | K902492 |
| Device Name: | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S |
| 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 |