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FDA 510(k)

Broncholab

K-Number: K191550 · 2020-03-04

ApplicantFluidda, Inc.
Decision Date2020-03-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Broncholab is a medical device manufactured by Fluidda, Inc.. It received FDA 510(k) clearance on 2020-03-04 under approval number K191550. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Broncholab?

Broncholab is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Fluidda, Inc.. The 510(k) number is K191550.

When was Broncholab approved by the FDA?

Broncholab received FDA 510(k) clearance on 2020-03-04, under approval number K191550.

What company makes Broncholab?

Broncholab is manufactured by Fluidda, Inc..

What is the FDA product code for Broncholab?

The FDA product code for Broncholab is JAK.

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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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