The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Cardiostat 1 Ecg Recorder.
| Device ID | K844392 |
| 510k Number | K844392 |
| Device Name: | CARDIOSTAT 1 ECG RECORDER |
| Classification | Electrocardiograph |
| Applicant | SIEMENS ELEMA AB 135 SOUTH LA SALLE ST. Chicago, IL 60603 |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius SIEMENS ELEMA AB 135 SOUTH LA SALLE ST. Chicago, IL 60603 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-04-11 |