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FDA 510(k)

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

K-Number: K181649 · 2019-01-11

ApplicantTrudell Medical International
Decision Date2019-01-11
Product CodeNVP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2019-01-11 under approval number K181649. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Trudell Medical International. The 510(k) number is K181649.

When was AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) approved by the FDA?

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) received FDA 510(k) clearance on 2019-01-11, under approval number K181649.

What company makes AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is manufactured by Trudell Medical International.

What is the FDA product code for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

The FDA product code for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is NVP.

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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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