The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Prucka Engineering Inc. Cardiolab Ep System,version 4.2.
| Device ID | K993414 |
| 510k Number | K993414 |
| Device Name: | PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 |
| Classification | Electrocardiograph |
| Applicant | PRUCKA ENGINEERING, INC. 13000 EXECUTIVE DR. Sugar Land, TX 77478 |
| Contact | Matthew W Prucka |
| Correspondent | Matthew W Prucka PRUCKA ENGINEERING, INC. 13000 EXECUTIVE DR. Sugar Land, TX 77478 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 2000-04-07 |
| Summary: | summary |