Cleared Traditional

AG 100s

K180991 · Hospitech Respiration , Ltd. · Anesthesiology
Oct 2018
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K180991 is an FDA 510(k) clearance for the AG 100s, 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 October 12, 2018, 179 days after receiving the submission on April 16, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K180991 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2018
Decision Date October 12, 2018
Days to Decision 179 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