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FDA 510(k)

Hudson RCI AquaPak Sterile Prefilled Nebulizers

K-Number: K153010 · 2016-07-26

ApplicantTeleflexmedical, Inc.
Decision Date2016-07-26
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI AquaPak Sterile Prefilled Nebulizers is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under approval number K153010. 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 Hudson RCI AquaPak Sterile Prefilled Nebulizers?

Hudson RCI AquaPak Sterile Prefilled Nebulizers is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K153010.

When was Hudson RCI AquaPak Sterile Prefilled Nebulizers approved by the FDA?

Hudson RCI AquaPak Sterile Prefilled Nebulizers received FDA 510(k) clearance on 2016-07-26, under approval number K153010.

What company makes Hudson RCI AquaPak Sterile Prefilled Nebulizers?

Hudson RCI AquaPak Sterile Prefilled Nebulizers is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers?

The FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers is CAF.

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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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