The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Resting Ecg Software Fro G-2000 Electrocardiograph.
| Device ID | K850322 |
| 510k Number | K850322 |
| Device Name: | RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
| Contact | Paul P Kluwe |
| Correspondent | Paul P Kluwe EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-05-16 |