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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 the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-01-11 under 510(k) 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. The listed applicant is Trudell Medical International. The 510(k) number is K181649.

When did AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) receive FDA 510(k) clearance?

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

Who is the listed applicant for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.

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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