Cleared Traditional

AUTOSET SPIRIT CPAP SYSTEM

K013843 · ResMed Corp · Anesthesiology
Jul 2002
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K013843 is an FDA 510(k) clearance for the AUTOSET SPIRIT CPAP SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (Poway, US). The FDA issued a Cleared decision on July 16, 2002, 238 days after receiving the submission on November 20, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K013843 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2001
Decision Date July 16, 2002
Days to Decision 238 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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