Cleared Traditional

THE HOOD LIFE SAVER

K853511 · Hood Laboratories · Anesthesiology
Dec 1985
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K853511 is an FDA 510(k) clearance for the THE HOOD LIFE SAVER, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on December 19, 1985, 120 days after receiving the submission on August 21, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K853511 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1985
Decision Date December 19, 1985
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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