Altech® Exhalation Valve (Single Limb And Dual Limb)

Valve, Non-rebreathing

Meditera Tibbi Malzeme San Ve TIC AS

The following data is part of a premarket notification filed by Meditera Tibbi Malzeme San Ve Tic As with the FDA for Altech® Exhalation Valve (single Limb And Dual Limb).

Pre-market Notification Details

• Device ID: K210992
• 510k Number: K210992
• Device Name: Altech® Exhalation Valve (Single Limb And Dual Limb)
• Classification: Valve, Non-rebreathing
• Applicant: Meditera Tibbi Malzeme San Ve TIC AS Ibni Melek OSB Mah, TOSHI Yol 4 Sol. No. 29 Tire Organize Sanayi Bolgesi Tire Izmir, TR 35900
• Contact: Cenk Kilic Kalkan
• Correspondent: Paul Dryden; Meditera Tibbi Malzeme San Ve TIC AS C/o ProMedic LLC 131 Bay Point Dr NE St. Petersburg, FL 33704
• Product Code: CBP
• CFR Regulation Number: 868.5870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-02
• Decision Date: 2021-12-23