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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K210992
Device Name Altech® Exhalation Valve (Single Limb and Dual Limb)
Applicant
Meditera Tibbi Malzeme San VE Tic AS
Ibni Melek Osb Mah, Toshi Yol 4 Sol. # 29 Tire
Organize Sanayi Bolgesi
Tire Izmir,  TR 35900
Applicant Contact Cenk Kilic Kalkan
Correspondent
Meditera Tibbi Malzeme San VE Tic AS C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5870
Classification Product Code
CBP  
Date Received04/02/2021
Decision Date 12/23/2021
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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