The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Pe Intercardiac Mapping System (icms).
| Device ID | K895916 |
| 510k Number | K895916 |
| Device Name: | PE INTERCARDIAC MAPPING SYSTEM (ICMS) |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | PRUCKA ENGINEERING, INC. 4710 BELLAIRE BLVD. SUITE 134 Bellaire, TX 77401 |
| Contact | Charles J Morina |
| Correspondent | Charles J Morina PRUCKA ENGINEERING, INC. 4710 BELLAIRE BLVD. SUITE 134 Bellaire, TX 77401 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1989-12-13 |