The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Wep-8430a Telemetry Central Station.
Device ID | K904696 |
510k Number | K904696 |
Device Name: | WEP-8430A TELEMETRY CENTRAL STATION |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
Contact | Mike Dashefsky |
Correspondent | Mike Dashefsky NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-15 |
Decision Date | 1991-02-07 |