BiNAPS Nasal Airflow and Snore Transducer +1 more— 510(k) K151874

Name: FDA 510(k) clearance K151874
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Substantially Equivalent

Salter Labs

FDA 510(k) clearance K151874 for BiNAPS Nasal Airflow and Snore Transducer +1 more, Substantially Equivalent on 2016-04-15. Applicant: Salter Labs. Device class: 2.

Clearance details

Device name as filed: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
Applicant: Salter Labs
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2015-07-09
Decision date: 2016-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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