Cleared Traditional

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

K151506 · Salter Labs · Anesthesiology
Mar 2016
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K151506 is an FDA 510(k) clearance for the Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on March 11, 2016, 281 days after receiving the submission on June 4, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K151506 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2015
Decision Date March 11, 2016
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NFB — Conserver, Oxygen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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