K771776 is an FDA 510(k) clearance for the ECG CLUSTER ELECTRODE. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977, 51 days after receiving the submission on September 19, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K771776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1977 |
| Decision Date | November 09, 1977 |
| Days to Decision | 51 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 |