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FDA 510(k)

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

K-Number: K151506 · 2016-03-11

ApplicantSalter Labs
Decision Date2016-03-11
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K151506. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Salter Labs. The 510(k) number is K151506.

When did Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula receive FDA 510(k) clearance?

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula received FDA 510(k) clearance on 2016-03-11, under 510(k) number K151506.

Who is the listed applicant for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

The FDA 510(k) record lists Salter Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

The FDA product code for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is NFB.

Related Clinical Trials

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.

NCT02824744Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in InfantsCOMPLETEDNCT03024112Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical PatientsCOMPLETEDNCT03472118High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General AnesthesiaTERMINATEDNCT03758508Non-invasive Ventilation Versus High Flow OxygenRECRUITINGNCT04055077Influence of HFNO on Respiratory Stability in Patients of Different ASA Risk During Moderate Multimodal Analgo-sedation for Pars Plana VitrectomyCOMPLETEDNCT05691218Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency DepartmentRECRUITING

Other records listing Salter Labs 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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuffK161719Salter Labs Bubble HumidifierK151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalK151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A Dynaris

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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