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FDA 510(k)

BreatheSuite MDI V1

K-Number: K203155 · 2021-09-17

ApplicantBreathesuite, Inc.
Decision Date2021-09-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BreatheSuite MDI V1 is a medical device manufactured by Breathesuite, Inc.. It received FDA 510(k) clearance on 2021-09-17 under approval number K203155. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BreatheSuite MDI V1?

BreatheSuite MDI V1 is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Breathesuite, Inc.. The 510(k) number is K203155.

When was BreatheSuite MDI V1 approved by the FDA?

BreatheSuite MDI V1 received FDA 510(k) clearance on 2021-09-17, under approval number K203155.

What company makes BreatheSuite MDI V1?

BreatheSuite MDI V1 is manufactured by Breathesuite, Inc..

What is the FDA product code for BreatheSuite MDI V1?

The FDA product code for BreatheSuite MDI V1 is CAF.

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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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