Cleared Traditional

DUAL-AID

K860949 · Vitalograph , Ltd. · Anesthesiology
May 1986
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K860949 is an FDA 510(k) clearance for the DUAL-AID, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on May 6, 1986, 55 days after receiving the submission on March 12, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K860949 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1986
Decision Date May 06, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

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