Cleared Traditional

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND

K962361 · Laerdal Medical Corp. · Anesthesiology
Sep 1996
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K962361 is an FDA 510(k) clearance for the TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND, a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Laerdal Medical Corp. (Wappingers Falls, US). The FDA issued a Cleared decision on September 5, 1996, 78 days after receiving the submission on June 19, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K962361 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1996
Decision Date September 05, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSR — Stylet, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5790

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