K832828 is an FDA 510(k) clearance for the CENTURION CARDIAC DETECTOR. This device is classified as a System, Signal Isolation (Class I - General Controls, product code DRJ).
Submitted by Clinical Data Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on May 9, 1984, 264 days after receiving the submission on August 19, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2600.
| 510(k) Number | K832828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1983 |
| Decision Date | May 09, 1984 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRJ — System, Signal Isolation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2600 |