Cleared Traditional

K151874 - BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
(FDA 510(k) Clearance)

K151874 · Salter Labs · Anesthesiology
Apr 2016
Decision
281d
Days
Class 2
Risk

K151874 is an FDA 510(k) clearance for the BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal. This device is classified as a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR).

Submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on April 15, 2016, 281 days after receiving the submission on July 9, 2015.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K151874 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2015
Decision Date April 15, 2016
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375