Altera Filter And HME/Filter

Filter, Bacterial, Breathing-circuit

Meditera Tibbi Malzeme San. Ve Tic. A.S.

The following data is part of a premarket notification filed by Meditera Tibbi Malzeme San. Ve Tic. A.s. with the FDA for Altera Filter And Hme/filter.

Pre-market Notification Details

• Device ID: K192713
• 510k Number: K192713
• Device Name: Altera Filter And HME/Filter
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: Meditera Tibbi Malzeme San. Ve Tic. A.S. Ibni Melek OSB Mah. TOSBI Yol 4 Sok No: 29 Tire Organize Sanayi Bolgesi, Tire Izmir, TR 35900
• Contact: Cenk Kilic Kalkan
• Correspondent: Paul Dryden; Meditera Tibbi Malzeme San. Ve Tic. A.S. % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-27
• Decision Date: 2020-03-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840117305878	K192713	000
00840117305854	K192713	000
M485AL08021V0012	K192713	000