K864583 is an FDA 510(k) clearance for the CARDIAC PERFORMANCE MONITOR. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Vascular Technology Incorporated (Attleboro, US). The FDA issued a Cleared decision on May 11, 1987, 172 days after receiving the submission on November 20, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K864583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1986 |
| Decision Date | May 11, 1987 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |