The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Eagle Monitor.
Device ID | K920790 |
510k Number | K920790 |
Device Name: | MARQUETTE EAGLE MONITOR |
Classification | Detector And Alarm, Arrhythmia |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Gerry Buss |
Correspondent | Gerry Buss MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-21 |
Decision Date | 1994-04-19 |