Cleared Traditional

BiWaze Clear System

K213564 · Abmrc, LLC · Anesthesiology
Dec 2022
Decision
407d
Days
Class 2
Risk

About This 510(k) Submission

K213564 is an FDA 510(k) clearance for the BiWaze Clear System, a Device, Positive Pressure Breathing, Intermittent (Class II — Special Controls, product code NHJ), submitted by Abmrc, LLC (Eagan, US). The FDA issued a Cleared decision on December 21, 2022, 407 days after receiving the submission on November 9, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K213564 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2021
Decision Date December 21, 2022
Days to Decision 407 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