BiNAPS Nasal Airflow And Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor With Airflow Pressure Cannulas, Nasal And Oral/Nasal

Ventilatory Effort Recorder

Salter Labs

The following data is part of a premarket notification filed by Salter Labs with the FDA for Binaps Nasal Airflow And Snore Transducer; Thermisense Oral/nasal Thermal Airflow Sensor With Airflow Pressure Cannulas, Nasal And Oral/nasal.

Pre-market Notification Details

• Device ID: K151874
• 510k Number: K151874
• Device Name: BiNAPS Nasal Airflow And Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor With Airflow Pressure Cannulas, Nasal And Oral/Nasal
• Classification: Ventilatory Effort Recorder
• Applicant: Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011
• Contact: Mara Caler
• Correspondent: Mara Caler; Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-09
• Decision Date: 2016-04-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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