The following data is part of a premarket notification filed by Herbert Stanley Co. with the FDA for Electrode Gel.
| Device ID | K884504 |
| 510k Number | K884504 |
| Device Name: | ELECTRODE GEL |
| Classification | Electrocardiograph |
| Applicant | HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Carl B Demasi |
| Correspondent | Carl B Demasi HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie, IL 60076 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1989-03-09 |