The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Pei Plaque Electrode Array.
| Device ID | K904747 |
| 510k Number | K904747 |
| Device Name: | PEI PLAQUE ELECTRODE ARRAY |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Contact | Steven Kim |
| Correspondent | Steven Kim PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-19 |
| Decision Date | 1991-10-09 |