The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Surgical Module 7000 Ecg.
Device ID | K840869 |
510k Number | K840869 |
Device Name: | SURGICAL MODULE 7000 ECG |
Classification | Electrocardiograph |
Applicant | MARQUETTE ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-27 |
Decision Date | 1985-02-06 |