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FDA 510(k)

Altera gas Sampling Lines

K-Number: K192563 · 2020-01-17

ApplicantMeditera Tibbi Malzeme San VE Tic AS
Decision Date2020-01-17
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Altera gas Sampling Lines is the device name listed in this FDA 510(k) record. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192563. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altera gas Sampling Lines?

Altera gas Sampling Lines is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K192563.

When did Altera gas Sampling Lines receive FDA 510(k) clearance?

Altera gas Sampling Lines received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192563.

Who is the listed applicant for Altera gas Sampling Lines?

The FDA 510(k) record lists Meditera Tibbi Malzeme San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altera gas Sampling Lines?

The FDA product code for Altera gas Sampling Lines is CCK.

Other records listing Meditera Tibbi Malzeme San VE Tic AS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210992Altech® Exhalation Valve (Single Limb and Dual Limb)K192713Altera Filter and HME/Filter

Related Devices (Code: CCK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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.

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