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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 K180991
Device Name AG 100s
Applicant
Hospitech Respiration , Ltd.
20 Hamagshimim St. Kiryat Matalon
Petach Tikva,  IL 49348
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number868.5750
Classification Product Code
BSK  
Date Received04/16/2018
Decision Date 10/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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