Cleared Traditional

K140951 - YEESCOPE LARYNGOSCOPES
(FDA 510(k) Clearance)

Nov 2014
Decision
210d
Days
Class 1
Risk

K140951 is an FDA 510(k) clearance for the YEESCOPE LARYNGOSCOPES. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).

Submitted by Yeescope Pty. , Ltd. (Kings Park, Nsw, AU). The FDA issued a Cleared decision on November 10, 2014, 210 days after receiving the submission on April 14, 2014.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number K140951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date November 10, 2014
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCW — Laryngoscope, Rigid
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5540

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