CASE-II

Electrocardiograph

MARQUETTE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Case-ii.

Pre-market Notification Details

Device IDK833458
510k NumberK833458
Device Name:CASE-II
ClassificationElectrocardiograph
Applicant MARQUETTE ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-06
Decision Date1983-11-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.