K960321 is an FDA 510(k) clearance for the CARDIOCATH CATHETERIZATION LAB SYSTEM. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Prucka Engineering, Inc. (Houston, US). The FDA issued a Cleared decision on August 21, 1996, 212 days after receiving the submission on January 22, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K960321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1996 |
| Decision Date | August 21, 1996 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |