Cleared Traditional

CPAP Cannulaide

K143700 · Salter Labs · Anesthesiology
Aug 2015
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K143700 is an FDA 510(k) clearance for the CPAP Cannulaide, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on August 5, 2015, 224 days after receiving the submission on December 24, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K143700 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2014
Decision Date August 05, 2015
Days to Decision 224 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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