Cleared Traditional

ILM ENDOTRACHEAL TUBE

K991580 · The Laryngeal Mask Co., Ltd. · Anesthesiology
Feb 2000
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K991580 is an FDA 510(k) clearance for the ILM ENDOTRACHEAL TUBE, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by The Laryngeal Mask Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on February 4, 2000, 273 days after receiving the submission on May 7, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K991580 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1999
Decision Date February 04, 2000
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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