The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Polyhesive Monitoring And Diagnostic Electrodes.
| Device ID | K885262 |
| 510k Number | K885262 |
| Device Name: | POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-23 |
| Decision Date | 1989-01-25 |