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FDA 510(k)

Breathe Easy Mobile Respiratory Monitor (MRM)

K-Number: K211387 · 2021-11-23

ApplicantSound Life Sciences, Inc.
Decision Date2021-11-23
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device manufactured by Sound Life Sciences, Inc.. It received FDA 510(k) clearance on 2021-11-23 under approval number K211387. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breathe Easy Mobile Respiratory Monitor (MRM)?

Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Sound Life Sciences, Inc.. The 510(k) number is K211387.

When was Breathe Easy Mobile Respiratory Monitor (MRM) approved by the FDA?

Breathe Easy Mobile Respiratory Monitor (MRM) received FDA 510(k) clearance on 2021-11-23, under approval number K211387.

What company makes Breathe Easy Mobile Respiratory Monitor (MRM)?

Breathe Easy Mobile Respiratory Monitor (MRM) is manufactured by Sound Life Sciences, Inc..

What is the FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM)?

The FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM) is BZQ.

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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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