The following data is part of a premarket notification filed by Corazonix Corp. with the FDA for Predictor Ii Signal Averaging Ecg.
| Device ID | K883855 |
| 510k Number | K883855 |
| Device Name: | PREDICTOR II SIGNAL AVERAGING ECG |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | CORAZONIX CORP. 4515 NORTH SANTA FE Oklahoma City, OK 73118 |
| Contact | James H Luby |
| Correspondent | James H Luby CORAZONIX CORP. 4515 NORTH SANTA FE Oklahoma City, OK 73118 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-03 |