Cleared Traditional

TRIBALL INCENTIVE SPIROMETER

K133873 · Besmed Health Business Corp · Anesthesiology
Apr 2014
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K133873 is an FDA 510(k) clearance for the TRIBALL INCENTIVE SPIROMETER, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Besmed Health Business Corp (New Taipei City, Wu-Ku District, TW). The FDA issued a Cleared decision on April 4, 2014, 105 days after receiving the submission on December 20, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K133873 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2013
Decision Date April 04, 2014
Days to Decision 105 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