The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Foam Ecg Electrodes.
| Device ID | K852177 |
| 510k Number | K852177 |
| Device Name: | FOAM ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | CLINICAL DATA, INC. BOX 430 Brookline, MA 02146 |
| Contact | Israel M Stein |
| Correspondent | Israel M 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 | 1985-05-20 |
| Decision Date | 1985-08-09 |