The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Pcx-100 Patient Input Leadwire.
| Device ID | K851632 |
| 510k Number | K851632 |
| Device Name: | PCX-100 PATIENT INPUT LEADWIRE |
| Classification | Adaptor, Lead Switching, 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 | DRW |
| CFR Regulation Number | 870.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-11-08 |