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FDA 510(k)

QOCA Portable ECG Monitoring Device

K-Number: K210179 · 2022-08-02

ApplicantQuanta Computer, Inc.
Decision Date2022-08-02
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QOCA Portable ECG Monitoring Device is a medical device manufactured by Quanta Computer, Inc.. It received FDA 510(k) clearance on 2022-08-02 under approval number K210179. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QOCA Portable ECG Monitoring Device?

QOCA Portable ECG Monitoring Device is a medical device that received FDA 510(k) clearance on 2022-08-02. It is manufactured by Quanta Computer, Inc.. The 510(k) number is K210179.

When was QOCA Portable ECG Monitoring Device approved by the FDA?

QOCA Portable ECG Monitoring Device received FDA 510(k) clearance on 2022-08-02, under approval number K210179.

What company makes QOCA Portable ECG Monitoring Device?

QOCA Portable ECG Monitoring Device is manufactured by Quanta Computer, Inc..

What is the FDA product code for QOCA Portable ECG Monitoring Device?

The FDA product code for QOCA Portable ECG Monitoring Device is DSH.

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Related PubMed Literature

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Official Source

View on FDA Database →

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