Cleared Traditional

BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER

K051313 · Salter Labs · Anesthesiology
Sep 2005
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K051313 is an FDA 510(k) clearance for the BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on September 15, 2005, 119 days after receiving the submission on May 19, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K051313 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2005
Decision Date September 15, 2005
Days to Decision 119 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

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