Cleared Traditional

ANAPNOGUARD ENDOTRACHEAL TUBE

K093126 · Hospitech Respiration , Ltd. · Anesthesiology
Mar 2010
Decision
151d
Days
Class 1
Risk

About This 510(k) Submission

K093126 is an FDA 510(k) clearance for the ANAPNOGUARD ENDOTRACHEAL TUBE, a Dropper, Ether (Class I — General Controls, product code BTP), submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on March 2, 2010, 151 days after receiving the submission on October 2, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5420.

Submission Details

510(k) Number K093126 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2009
Decision Date March 02, 2010
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTP — Dropper, Ether
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5420