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Performance Plan – AeroChamber Plus Flow-Vu (K181649)
Performance Plan – AeroChamber Plus Flow-Vu (K181649)
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510(K) Number: K181649
Device Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Manufacturer: Trudell Medical International
Device Classification Name: Holding Chambers, Direct Patient Interface
Regulation Number: 868.5630
Classification Product Code: NVP
Date Received: 06/22/2018
Decision Date: 01/11/2019
Regulation Medical Specialty: Anesthesiology
Request Contents: Performance plan and report for predicate device compared to K181649, Trade Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber, Classification: Holding Chambers, Direct Patient Interface, 21 CFR 868.5630, Regulatory Class II, Product Code: NVP.
Device Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Manufacturer: Trudell Medical International
Device Classification Name: Holding Chambers, Direct Patient Interface
Regulation Number: 868.5630
Classification Product Code: NVP
Date Received: 06/22/2018
Decision Date: 01/11/2019
Regulation Medical Specialty: Anesthesiology
Request Contents: Performance plan and report for predicate device compared to K181649, Trade Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber, Classification: Holding Chambers, Direct Patient Interface, 21 CFR 868.5630, Regulatory Class II, Product Code: NVP.
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