The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Eagle 3000 Patient Monitor.
Device ID | K952474 |
510k Number | K952474 |
Device Name: | EAGLE 3000 PATIENT MONITOR |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Dianne Schmitz |
Correspondent | Dianne Schmitz MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-30 |
Decision Date | 1995-10-19 |