The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Trace Rite Solid Gel Ecg Electrodes.
| Device ID | K964213 |
| 510k Number | K964213 |
| Device Name: | TRACE RITE SOLID GEL ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
| Contact | Michael R Dupelle |
| Correspondent | Michael R Dupelle BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-11-25 |