Altera Filter and HME/Filter
K-Number: K192713 · 2020-03-16
ApplicantMeditera Tibbi Malzeme San VE Tic AS
Decision Date2020-03-16
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Altera Filter and HME/Filter is a medical device manufactured by Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2020-03-16 under approval number K192713. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Altera Filter and HME/Filter?
Altera Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K192713.
When was Altera Filter and HME/Filter approved by the FDA?
Altera Filter and HME/Filter received FDA 510(k) clearance on 2020-03-16, under approval number K192713.
What company makes Altera Filter and HME/Filter?
Altera Filter and HME/Filter is manufactured by Meditera Tibbi Malzeme San VE Tic AS.
What is the FDA product code for Altera Filter and HME/Filter?
The FDA product code for Altera Filter and HME/Filter is CAH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.