The following data is part of a premarket notification filed by Echo Ultrasound with the FDA for Sterilized Omni Gel.
| Device ID | K872519 |
| 510k Number | K872519 |
| Device Name: | STERILIZED OMNI GEL |
| Classification | Electrode, Gel, Electrosurgical |
| Applicant | ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Contact | David Szczupakowski |
| Correspondent | David Szczupakowski ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Product Code | JOT |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-25 |
| Decision Date | 1987-08-03 |