The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Rmg-9 9 Remote Monitor Access. For G-2000 Electro.
| Device ID | K851628 |
| 510k Number | K851628 |
| Device Name: | RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO |
| Classification | Display, Cathode-ray Tube, Medical |
| 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 | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-06-27 |