K850702 is an FDA 510(k) clearance for the CARDIOVIT CS-6 ECG-RECORDER. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Schiller AG (Switzerland, CH). The FDA issued a Cleared decision on April 25, 1985, 63 days after receiving the submission on February 21, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K850702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1985 |
| Decision Date | April 25, 1985 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |