The following data is part of a premarket notification filed by Coherent Systems, Inc. with the FDA for Ep-stat.
| Device ID | K883152 |
| 510k Number | K883152 |
| Device Name: | EP-STAT |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | COHERENT SYSTEMS, INC. 4111 TOWNES FOREST Friendswood, TX 77546 |
| Contact | Robert Mecalo |
| Correspondent | Robert Mecalo COHERENT SYSTEMS, INC. 4111 TOWNES FOREST Friendswood, TX 77546 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-10-13 |