The following data is part of a premarket notification filed by Nasiff Assoc., Inc. with the FDA for Cardio-card Ecg Management System.
| Device ID | K920020 |
| 510k Number | K920020 |
| Device Name: | CARDIO-CARD ECG MANAGEMENT SYSTEM |
| Classification | Electrocardiograph |
| Applicant | NASIFF ASSOC., INC. P.O. BOX 88 Brewerton, NY 13029 |
| Contact | Roger Nasiff |
| Correspondent | Roger Nasiff NASIFF ASSOC., INC. P.O. BOX 88 Brewerton, NY 13029 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-02 |
| Decision Date | 1992-07-09 |