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FDA 510(k)

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

K-Number: K151874 · 2016-04-15

ApplicantSalter Labs
Decision Date2016-04-15
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Salter Labs. The 510(k) number is K151874.

When was BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal approved by the FDA?

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 approval number K151874.

What company makes 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 manufactured by Salter Labs.

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.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED NCT07116408 Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07600333 CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children NOT_YET_RECRUITING

Other Devices by Salter Labs

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 K161719Salter Labs Bubble Humidifier

Related Devices (Code: MNR)

K153070Watch-PAT200UItamar Medical , Ltd. K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. K163696SleepImage SystemMycardio, LLC Dba Sleepimage. K163665MATRx plusZephyr Sleep Technologies K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical K161579Watch-PAT200UItamar Medical , Ltd.

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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