The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Disposable Ecg Monitoring Electrode.
| Device ID | K863904 |
| 510k Number | K863904 |
| Device Name: | DISPOSABLE ECG MONITORING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CLINICAL DATA, INC. BOX 430 Brookline, MA 02146 |
| Contact | Israel Stein |
| Correspondent | Israel Stein CLINICAL DATA, INC. BOX 430 Brookline, MA 02146 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-07 |
| Decision Date | 1987-01-06 |