The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit Cs-6 Ecg-recorder.
| Device ID | K850702 |
| 510k Number | K850702 |
| Device Name: | CARDIOVIT CS-6 ECG-RECORDER |
| Classification | Electrocardiograph |
| Applicant | SCHILLER AG CH-6340 BAAR, ALTGASSE 68 Switzerland, CH |
| Contact | Peter Weber |
| Correspondent | Peter Weber SCHILLER AG CH-6340 BAAR, ALTGASSE 68 Switzerland, CH |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-04-25 |