The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap(tm) Dr-104 Reporter.
| Device ID | K885058 |
| 510k Number | K885058 |
| Device Name: | CARDIOCAP(TM) DR-104 REPORTER |
| Classification | Recorder, Paper Chart |
| 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 | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-07 |
| Decision Date | 1989-07-14 |