Cleared Traditional

AO STYLET LARYNGOSCOPE, MODEL SLS-1

K791634 · American Optical Corp. · Anesthesiology
Sep 1979
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K791634 is an FDA 510(k) clearance for the AO STYLET LARYNGOSCOPE, MODEL SLS-1, 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 September 17, 1979, 27 days after receiving the submission on August 21, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number K791634 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date September 17, 1979
Days to Decision 27 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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