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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K151874
Device Name BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
Applicant
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Applicant Contact Mara Caler
Correspondent
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Correspondent Contact Mara Caler
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
BZQ  
Date Received07/09/2015
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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