The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Recording Accessory For G-2000 Ekg Mach. Gmp-40 Re.
| Device ID | K850365 |
| 510k Number | K850365 |
| Device Name: | RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE |
| Classification | Recorder, Paper Chart |
| 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 | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-04-09 |