FDA 510(k)

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

Número K: K151874 · 2016-04-15

Data da decisão2016-04-15

Código do produtoMNR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K151874. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal?

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Salter Labs. The 510(k) number is K151874.

When did BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal receive FDA 510(k) clearance?

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal received FDA 510(k) clearance on 2016-04-15, under 510(k) number K151874.

Who is the listed applicant for BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal?

O registro FDA 510(k) lista Salter Labs como o solicitante. Isso por si só não estabelece o fabricante do dispositivo.

What is the FDA product code for BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal?

The FDA product code for BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is MNR.

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Outros registros que listam Salter Labs como candidato(a)

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K161719Salter Labs Bubble Humidifier K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Dispositivos Relacionados (Código: MNR)

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Fonte oficial

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