Cleared Traditional

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM

K040202 · Salter Labs · Anesthesiology
Mar 2005
Decision
400d
Days
Class 2
Risk

About This 510(k) Submission

K040202 is an FDA 510(k) clearance for the SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on March 4, 2005, 400 days after receiving the submission on January 29, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K040202 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2004
Decision Date March 04, 2005
Days to Decision 400 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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