K781163 is an FDA 510(k) clearance for the ELECTRODE, DEIP.. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1978, 76 days after receiving the submission on July 12, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K781163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1978 |
| Decision Date | September 26, 1978 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRX - Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |