Lite-Blade

FDA 510(k) K944428 · Eare Consulting Service

Substantially Equivalent

510(k) numberK944428

Submission

Device name
Lite-Blade
Applicant
Eare Consulting Service
Eilat, IL
Received
September 12, 1994
Decision date
November 15, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCW – Laryngoscope, Rigid
Device class
Class I (low risk)
Regulation
21 CFR 868.5540
Specialty
Anesthesiology

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K140951Yeescope LaryngoscopesCCW · Traditional Yeescope Pty. , Ltd.11/10/2014SE
K121378Airtraq SP Airtraq AvantCCW · Traditional Prodol Meditec , Ltd.06/21/2012SE
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K062231MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special Minrad, Inc.08/31/2006SE
K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · Special Minrad, Inc.08/31/2006SE
K041852MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional Minrad, Inc.11/15/2004SE
K984101FlexibladeCCW · Traditional Arco Medic , Ltd.09/03/1999SE

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Questions and answers

When was Lite-Blade cleared by the FDA?

Lite-Blade (K944428) received a 510(k) decision of Substantially Equivalent on November 15, 1994, 64 days after the submission was received.

What is the product code of K944428?

The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.