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FDA 510(k)

Life Sensor Cardiac Monitor

K-Number: K191331 · 2019-06-12

ApplicantBraveheart Wireless, Inc.
Decision Date2019-06-12
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Life Sensor Cardiac Monitor is a medical device manufactured by Braveheart Wireless, Inc.. It received FDA 510(k) clearance on 2019-06-12 under approval number K191331. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Sensor Cardiac Monitor?

Life Sensor Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by Braveheart Wireless, Inc.. The 510(k) number is K191331.

When was Life Sensor Cardiac Monitor approved by the FDA?

Life Sensor Cardiac Monitor received FDA 510(k) clearance on 2019-06-12, under approval number K191331.

What company makes Life Sensor Cardiac Monitor?

Life Sensor Cardiac Monitor is manufactured by Braveheart Wireless, Inc..

What is the FDA product code for Life Sensor Cardiac Monitor?

The FDA product code for Life Sensor Cardiac Monitor is DRG.

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Official Source

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

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