The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Series 7200 Transport/remote Acquisition Monitor.
Device ID | K860734 |
510k Number | K860734 |
Device Name: | SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR |
Classification | Electrocardiograph |
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 | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-27 |
Decision Date | 1986-11-06 |