Prucka Engineering, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K993414 | PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 | April 7, 2000 |
| K960321 | CARDIOCATH CATHETERIZATION LAB SYSTEM | August 21, 1996 |
| K904747 | PEI PLAQUE ELECTRODE ARRAY | October 9, 1991 |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | April 12, 1991 |
| K902716 | PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) | September 4, 1990 |
| K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) | December 13, 1989 |