K896396 is an FDA 510(k) clearance for the MIDA SYSTEM, MODELS 1000/1100. This device is classified as a Vectorcardiograph (Class II - Special Controls, product code DYC).
Submitted by Medical Graphics Corp. (Findley, US). The FDA issued a Cleared decision on January 18, 1990, 73 days after receiving the submission on November 6, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2400.
| 510(k) Number | K896396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1989 |
| Decision Date | January 18, 1990 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYC — Vectorcardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2400 |