The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Ekgcard System.
| Device ID | K030535 |
| 510k Number | K030535 |
| Device Name: | EKGCARD SYSTEM |
| Classification | Electrocardiograph |
| Applicant | QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447 |
| Contact | Brad Sorenson |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-06-11 |
| Summary: | summary |