The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap(tm) Cto-104 Monitor.
| Device ID | K884956 |
| 510k Number | K884956 |
| Device Name: | CARDIOCAP(TM) CTO-104 MONITOR |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-29 |
| Decision Date | 1988-12-27 |