K840020 is an FDA 510(k) clearance for the FITNESS LOGGER. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Britt Corp., Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 26, 1984, 295 days after receiving the submission on January 5, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K840020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | January 05, 1984 |
| Decision Date | October 26, 1984 |
| Days to Decision | 295 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 |