The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Cardiofax-v Ecg-8240a.
Device ID | K865030 |
510k Number | K865030 |
Device Name: | CARDIOFAX-V ECG-8240A |
Classification | Detector And Alarm, Arrhythmia |
Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
Contact | Jan Sebens |
Correspondent | Jan Sebens 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 | 1986-12-23 |
Decision Date | 1987-03-10 |