The following data is part of a premarket notification filed by Telemed Div. with the FDA for Omnigraph 4000(electrocardiograph).
| Device ID | K852652 |
| 510k Number | K852652 |
| Device Name: | OMNIGRAPH 4000(ELECTROCARDIOGRAPH) |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | TELEMED DIV. 2345 PEMBROKE AVE. Hoffman Estates, IL 60195 |
| Contact | Samuel L Stancer |
| Correspondent | Samuel L Stancer TELEMED DIV. 2345 PEMBROKE AVE. Hoffman Estates, IL 60195 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-21 |
| Decision Date | 1985-11-19 |