The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for Cardisuny 501biii.
| Device ID | K901948 |
| 510k Number | K901948 |
| Device Name: | CARDISUNY 501BIII |
| Classification | Electrocardiograph |
| Applicant | GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Contact | Maria Simat |
| Correspondent | Maria Simat GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-07-17 |