The following data is part of a premarket notification filed by Corazonic Corp. with the FDA for Modified Predictor Iic Signal Averaging Ecg.
| Device ID | K915760 |
| 510k Number | K915760 |
| Device Name: | MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG |
| Classification | Electrocardiograph |
| Applicant | CORAZONIC CORP. 4515 NORTH SANTA FE Oklahoma City, OK 73118 |
| Contact | James H Luby |
| Correspondent | James H Luby CORAZONIC CORP. 4515 NORTH SANTA FE Oklahoma City, OK 73118 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-02-14 |