The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Dual Lead (ecg1 & Ecg2) Arrhythmia Analysis.
| Device ID | K920743 |
| 510k Number | K920743 |
| Device Name: | DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Hayim Zadaca |
| Correspondent | Hayim Zadaca NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-09-03 |