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FDA 510(k)

Hudson RCI Voldyne Volumetric Exerciser

K-Number: K182847 · 2019-07-01

ApplicantTeleflexmedical, Inc.
Decision Date2019-07-01
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI Voldyne Volumetric Exerciser is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K182847. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI Voldyne Volumetric Exerciser?

Hudson RCI Voldyne Volumetric Exerciser is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K182847.

When did Hudson RCI Voldyne Volumetric Exerciser receive FDA 510(k) clearance?

Hudson RCI Voldyne Volumetric Exerciser received FDA 510(k) clearance on 2019-07-01, under 510(k) number K182847.

Who is the listed applicant for Hudson RCI Voldyne Volumetric Exerciser?

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

What is the FDA product code for Hudson RCI Voldyne Volumetric Exerciser?

The FDA product code for Hudson RCI Voldyne Volumetric Exerciser is BWF.

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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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