Cleared Traditional

VIBRALUNG ACOUSTICAL PERCUSSOR

K133057 · Westmed, Inc. · Anesthesiology
May 2014
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K133057 is an FDA 510(k) clearance for the VIBRALUNG ACOUSTICAL PERCUSSOR, a Intra-pulmonary Percussive Vibration (ipv) Devices (Class II — Special Controls, product code SDT), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on May 23, 2014, 238 days after receiving the submission on September 27, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5665.

Submission Details

510(k) Number K133057 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2013
Decision Date May 23, 2014
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code SDT — Intra-pulmonary Percussive Vibration (ipv) Devices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5665
Definition It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways.