The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap Dr-124 Recorder.
| Device ID | K910620 |
| 510k Number | K910620 |
| Device Name: | CARDIOCAP DR-124 RECORDER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| 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 | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-05-07 |