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FDA 510(k)

Hudson RCI Variable concentration Large Volume Nebulizer (1770)

K-Number: K220955 · 2023-06-23

ApplicantMedline Industires, Inc.
Decision Date2023-06-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI Variable concentration Large Volume Nebulizer (1770) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K220955. 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 Variable concentration Large Volume Nebulizer (1770)?

Hudson RCI Variable concentration Large Volume Nebulizer (1770) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Medline Industires, Inc.. The 510(k) number is K220955.

When did Hudson RCI Variable concentration Large Volume Nebulizer (1770) receive FDA 510(k) clearance?

Hudson RCI Variable concentration Large Volume Nebulizer (1770) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K220955.

Who is the listed applicant for Hudson RCI Variable concentration Large Volume Nebulizer (1770)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hudson RCI Variable concentration Large Volume Nebulizer (1770)?

The FDA product code for Hudson RCI Variable concentration Large Volume Nebulizer (1770) is CAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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