The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Wep-8430a Central Telemetry System.
| Device ID | K945944 |
| 510k Number | K945944 |
| Device Name: | NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Penni L Pannell |
| Correspondent | Penni L Pannell NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-05 |
| Decision Date | 1995-11-27 |