Cleared Traditional

Salter Labs Bubble Humidifier

K161719 · Salter Labs · Anesthesiology
Sep 2017
Decision
456d
Days
Class 2
Risk

About This 510(k) Submission

K161719 is an FDA 510(k) clearance for the Salter Labs Bubble Humidifier, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on September 21, 2017, 456 days after receiving the submission on June 22, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K161719 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2016
Decision Date September 21, 2017
Days to Decision 456 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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