The following data is part of a premarket notification filed by Telemed Div. with the FDA for Omnigraph 6000.
| Device ID | K880357 |
| 510k Number | K880357 |
| Device Name: | OMNIGRAPH 6000 |
| Classification | Electrocardiograph |
| Applicant | TELEMED DIV. 2345 PEMBROKE AVE. Hoffman Estates, IL 60195 |
| Contact | Frank Lavalle |
| Correspondent | Frank Lavalle TELEMED DIV. 2345 PEMBROKE AVE. Hoffman Estates, IL 60195 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-28 |
| Decision Date | 1988-08-02 |