The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Series 2000 Bedside Patient Monitor.
Device ID | K872354 |
510k Number | K872354 |
Device Name: | SERIES 2000 BEDSIDE PATIENT MONITOR |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Thomas Massopust |
Correspondent | Thomas Massopust 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 | 1987-06-18 |
Decision Date | 1987-07-21 |