Cleared Traditional

OLYMPUS LF-1 INTUBATION SCOPE

K850978 · Olympus Corp. · Anesthesiology
May 1985
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K850978 is an FDA 510(k) clearance for the OLYMPUS LF-1 INTUBATION SCOPE, a Laryngoscope, Non-rigid (Class I — General Controls, product code CAL), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on May 23, 1985, 76 days after receiving the submission on March 8, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number K850978 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1985
Decision Date May 23, 1985
Days to Decision 76 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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