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FDA 510(k)

CardiMax Electrocardiograph

K-Number: K173226 · 2018-04-16

ApplicantFukuda Denshi USA, Inc.
Decision Date2018-04-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardiMax Electrocardiograph is a medical device manufactured by Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2018-04-16 under approval number K173226. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardiMax Electrocardiograph?

CardiMax Electrocardiograph is a medical device that received FDA 510(k) clearance on 2018-04-16. It is manufactured by Fukuda Denshi USA, Inc.. The 510(k) number is K173226.

When was CardiMax Electrocardiograph approved by the FDA?

CardiMax Electrocardiograph received FDA 510(k) clearance on 2018-04-16, under approval number K173226.

What company makes CardiMax Electrocardiograph?

CardiMax Electrocardiograph is manufactured by Fukuda Denshi USA, Inc..

What is the FDA product code for CardiMax Electrocardiograph?

The FDA product code for CardiMax Electrocardiograph is DPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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