The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Central Station Display/recorder Matrix.
Device ID | K830517 |
510k Number | K830517 |
Device Name: | CENTRAL STATION DISPLAY/RECORDER MATRIX |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | MARQUETTE ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-17 |
Decision Date | 1983-06-15 |