The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Lx-3240 Ecg & Respiratory Transmitter.
Device ID | K963057 |
510k Number | K963057 |
Device Name: | FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER |
Classification | Detector And Alarm, Arrhythmia |
Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
Contact | David J Geraghty |
Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-06 |
Decision Date | 1997-03-21 |