Cleared Special

REMSTAR AUTO A-FLEX HT

K131982 · Respironics, Inc. · Anesthesiology
Oct 2013
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K131982 is an FDA 510(k) clearance for the REMSTAR AUTO A-FLEX HT, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 18, 2013, 112 days after receiving the submission on June 28, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K131982 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date October 18, 2013
Days to Decision 112 days
Submission Type Special
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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