Cleared Traditional

AO STYLET LARYNGOSCOPE MODEL SLS

K801364 · American Optical Corp. · Anesthesiology
Jun 1980
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K801364 is an FDA 510(k) clearance for the AO STYLET LARYNGOSCOPE MODEL SLS, a Laryngoscope, Non-rigid (Class I — General Controls, product code CAL), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980, 7 days after receiving the submission on June 10, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number K801364 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1980
Decision Date June 17, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAL — Laryngoscope, Non-rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5530

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