Cleared Traditional

Hudson RCI Voldyne Volumetric Exerciser

K182847 · Teleflexmedical, Inc. · Anesthesiology
Jul 2019
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K182847 is an FDA 510(k) clearance for the Hudson RCI Voldyne Volumetric Exerciser, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 1, 2019, 265 days after receiving the submission on October 9, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K182847 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2018
Decision Date July 01, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690