Cleared Traditional

Altera Filter and HME/Filter

K192713 · Meditera Tibbi Malzeme San VE Tic AS · General Hospital
Mar 2020
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K192713 is an FDA 510(k) clearance for the Altera Filter and HME/Filter, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Meditera Tibbi Malzeme San VE Tic AS (Izmir, TR). The FDA issued a Cleared decision on March 16, 2020, 171 days after receiving the submission on September 27, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K192713 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2019
Decision Date March 16, 2020
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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