Cleared Traditional

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

K123400 · Trudell Medical Intl. · Anesthesiology
May 2013
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K123400 is an FDA 510(k) clearance for the AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on May 16, 2013, 192 days after receiving the submission on November 5, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K123400 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2012
Decision Date May 16, 2013
Days to Decision 192 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