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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K171411
Device Name IRRIS (Infra-Red-Red Intubation System)
A.R Guide In Medical Ltd.
13 Wadi El Haj
Nazareth,  IL 17111
Applicant Contact Ariel Shrem
MedicSense, USA
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact George J. Hattub
Regulation Number868.5730
Classification Product Code
Date Received05/15/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No