The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Cardiocath Catheterization Lab System.
| Device ID | K960321 |
| 510k Number | K960321 |
| Device Name: | CARDIOCATH CATHETERIZATION LAB SYSTEM |
| Classification | Electrocardiograph |
| Applicant | PRUCKA ENGINEERING, INC. 8050 EL RIO Houston, TX 77054 |
| Contact | Matthew W Prucka |
| Correspondent | Matthew W Prucka PRUCKA ENGINEERING, INC. 8050 EL RIO Houston, TX 77054 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-08-21 |
| Summary: | summary |