The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Pe Electrophysiology Lab System (peep).
| Device ID | K902716 |
| 510k Number | K902716 |
| Device Name: | PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Contact | Sheryl S Prucka |
| Correspondent | Sheryl S Prucka PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-20 |
| Decision Date | 1990-09-04 |