Cleared Traditional

BiWaze Cough

K191912 · Abmrc, LLC · Anesthesiology
Mar 2020
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K191912 is an FDA 510(k) clearance for the BiWaze Cough, a Device, Positive Pressure Breathing, Intermittent (Class II — Special Controls, product code NHJ), submitted by Abmrc, LLC (Charleston, US). The FDA issued a Cleared decision on March 27, 2020, 254 days after receiving the submission on July 17, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K191912 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2019
Decision Date March 27, 2020
Days to Decision 254 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NHJ — Device, Positive Pressure Breathing, Intermittent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905