The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Cardiostat 3 Recorder.
| Device ID | K851044 |
| 510k Number | K851044 |
| Device Name: | CARDIOSTAT 3 RECORDER |
| Classification | Electrocardiograph |
| Applicant | SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Contact | Anders Thoren |
| Correspondent | Anders Thoren SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-06-26 |