The following data is part of a premarket notification filed by Contour Electrodes, Inc. with the FDA for Contour Soft-e Series Conductive Solid Gel Electro.
| Device ID | K871412 |
| 510k Number | K871412 |
| Device Name: | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Contact | Keith Ferrari |
| Correspondent | Keith Ferrari CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-08 |
| Decision Date | 1987-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838006809 | K871412 | 000 |
| 20884838006786 | K871412 | 000 |
| 20884838006779 | K871412 | 000 |
| 20884838006755 | K871412 | 000 |
| 20884838000906 | K871412 | 000 |
| 20884838000890 | K871412 | 000 |
| 20884838000883 | K871412 | 000 |
| 20884838000876 | K871412 | 000 |