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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K150157
Device Name AnapnoGuard 100 Respiratory Guard System
Applicant
HOSPITECH RESPIRATION LTD.
20 HAMAGSHIMIM ST. KIRYAT MATALON
PETACH TIKVA,  IL 49348
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda Street
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number868.5750
Classification Product Code
BSK  
Subsequent Product Code
BTR  
Date Received01/23/2015
Decision Date 02/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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