Cleared Traditional

K150591 - Besmed Reusable Jet Nebulizer (FDA 510(k) Clearance)

K150591 · Besmed Health Business Corp · Anesthesiology device
Jun 2015
Decision
113d
Days
Class 2
Risk

K150591 is an FDA 510(k) clearance for the Besmed Reusable Jet Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).

Submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on June 30, 2015, 113 days after receiving the submission on March 9, 2015.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K150591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2015
Decision Date June 30, 2015
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF - Nebulizer (direct Patient Interface)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5630