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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 the device name listed in this FDA 510(k) record. The listed applicant is Breathesuite, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) 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. The listed applicant is Breathesuite, Inc.. The 510(k) number is K203155.

When did BreatheSuite MDI V1 receive FDA 510(k) clearance?

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

Who is the listed applicant for BreatheSuite MDI V1?

The FDA 510(k) record lists Breathesuite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BreatheSuite MDI V1?

The FDA product code for BreatheSuite MDI V1 is CAF.

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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