Laryngoscope Cover

FDA 510(k) K945301 · Sotiria Mourkidou, M.D.

Substantially Equivalent

510(k) numberK945301

Submission

Device name
Laryngoscope Cover
Applicant
Sotiria Mourkidou, M.D.
Malibu, CA, US
Received
October 31, 1994
Decision date
May 31, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code CCW

510(k)DeviceApplicantDecision
K191602APA Oxy BladeCCW · Traditional Venner Medical (Singapore) Pte, Ltd.08/02/2019SE
K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)CCW · Traditional Girgis Scope, LLC06/22/2017SE
K140951Yeescope LaryngoscopesCCW · Traditional Yeescope Pty. , Ltd.11/10/2014SE
K121378Airtraq SP Airtraq AvantCCW · Traditional Prodol Meditec , Ltd.06/21/2012SE
K063477Novamed MRI Conditional Laryngoscope SetCCW · Traditional Novamed, LLC02/09/2007SE
K062523Tru-Mr Laryngoscope SetCCW · Traditional Truphatek International, Ltd.11/17/2006SE
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

Questions and answers

When was Laryngoscope Cover cleared by the FDA?

Laryngoscope Cover (K945301) received a 510(k) decision of Substantially Equivalent on May 31, 1996, 578 days after the submission was received.

What is the product code of K945301?

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