Cleared Traditional

AnapnoGuard 100 Respiratory Guard System

K150157 · Hospitech Respiration , Ltd. · Anesthesiology
Feb 2016
Decision
389d
Days
Class 2
Risk

About This 510(k) Submission

K150157 is an FDA 510(k) clearance for the AnapnoGuard 100 Respiratory Guard System, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Hospitech Respiration , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on February 16, 2016, 389 days after receiving the submission on January 23, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K150157 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2015
Decision Date February 16, 2016
Days to Decision 389 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750