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FDA 510(k)

Quantitative Electrocardiographic Detector (QED 2000)

K-Number: K152135 · 2016-08-09

ApplicantAcme Portable Machines, Inc.
Decision Date2016-08-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantitative Electrocardiographic Detector (QED 2000) is a medical device manufactured by Acme Portable Machines, Inc.. It received FDA 510(k) clearance on 2016-08-09 under approval number K152135. 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 Quantitative Electrocardiographic Detector (QED 2000)?

Quantitative Electrocardiographic Detector (QED 2000) is a medical device that received FDA 510(k) clearance on 2016-08-09. It is manufactured by Acme Portable Machines, Inc.. The 510(k) number is K152135.

When was Quantitative Electrocardiographic Detector (QED 2000) approved by the FDA?

Quantitative Electrocardiographic Detector (QED 2000) received FDA 510(k) clearance on 2016-08-09, under approval number K152135.

What company makes Quantitative Electrocardiographic Detector (QED 2000)?

Quantitative Electrocardiographic Detector (QED 2000) is manufactured by Acme Portable Machines, Inc..

What is the FDA product code for Quantitative Electrocardiographic Detector (QED 2000)?

The FDA product code for Quantitative Electrocardiographic Detector (QED 2000) is DPS.

Related Clinical Trials

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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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