FDA 510(k)

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

K-Nummer: K151421 · 2016-03-10

Entscheidungsdatum2016-03-10

ProduktcodeCCK

BeratungsausschussAN

EntscheidungSubstantially Equivalent

Produktübersicht

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K151421. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Salter Labs. The 510(k) number is K151421.

When did Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines receive FDA 510(k) clearance?

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151421.

Who is the listed applicant for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

Das FDA 510(k)-Buchungsdokument listet Salter Labs als Antragsteller. Dies stellt an sich den Hersteller des Geräts nicht dar.

What is the FDA product code for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

The FDA product code for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is CCK.

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Weitere Einträge mit Salter Labs als Antragsteller

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K161719Salter Labs Bubble Humidifier K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

Verwandte Geräte (Code: CCK)

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation K261633VisuBreathAffirm Medical Technologies II, LLC K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation K2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

Offizielle Quelle

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