The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Full-disclosure Ambulatory Ecg System.
| Device ID | K823529 |
| 510k Number | K823529 |
| Device Name: | FULL-DISCLOSURE AMBULATORY ECG SYSTEM |
| Classification | Electrocardiograph |
| Applicant | CLINICAL DATA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1982-12-15 |